[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"weight-gain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:weight-gain":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,48,61,88,116,150,177,209,236,261,289,316,342,366,397,430,459,488,511,545,566,597,623],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054044","phase-2-early-metabolic-effects-of-antiretroviral-drugs-in-healthy-volunteers-a-phase-2-randomized-study-100054044",false,"NCT05652478","Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study","Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 18 to 55 years.\n* Able to provide informed consent.\n* Willing to allow samples and data to be stored and shared for future research.\n* Agrees to use a barrier method of contraception or abstain from sexual activity starting at screening though the end of study participation.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Current infection with HIV or hepatitis A, B, or C.\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm\\^2 or \\>30.0 kg\u002Fm\\^2.\n* Weight change \\>5% in the past 6 months.\n* History of or current cardiovascular disease such as congestive heart failure, heart block, or clinically relevant abnormal ECG as determined by investigators.\n* History of or current liver disease or alanine transaminase serum level \\>2x upper limit of normal.\n* History of or current kidney disease or renal insufficiency, or estimated creatinine clearance \\\u003C=80 mL\u002Fmin (Modification of Diet in Renal Disease equation).\n* Current cancer or history of cancer within 5 years of screening, with the exception of squamous cell carcinoma or basal cell carcinoma that is localized and does not require systemic therapy.\n* History of bariatric surgery.\n* Diabetes mellitus as defined by a prior diagnosis or a hemoglobin A1c of \\>6.4 percent on screening labs.\n* Fasting serum glucose \\>126 mg\u002FdL.\n* History of or current hypo- or hyper-thyroid or abnormal TSH, except minor deviations deemed to be of no clinical significance by the investigator.\n* History of or current asthma or chronic obstructive pulmonary disease.\n* Psychological conditions by self-report, such as (but not limited to) clinical depression, bipolar disorders, which would be incompatible with safe and successful participation in this study.\n* Pregnancy or within 1 year post-partum.\n* Breastfeeding.\n* Blood pressure \\>140\u002F90 mm Hg or current antihypertensive therapy.\n* Hemoglobin that is either 10 percent below the lower limit or 10 percent above the upper limit of the normal range for the Clinical Center Laboratory (acceptable ranges: females 10.08-17.27 g\u002FdL, males 12.33-19.25 g\u002FdL).\n* History of illicit drug, opioid, or alcohol abuse within the last 5 years; current use of illicit drugs or opioids (by history) or excessive alcohol (CAGE assessment score \\>=2).\n* Current use of the following prescription or over-the-counter medications and supplements:\n\n  * Carbamazepine\n  * Oxcarbazepine\n  * Phenobarbital\n  * Phenytoin\n  * Primidone\n  * Rifabutin\n  * Rifampin\n  * Rifapentine\n  * St. John's wort (Hypericum perforatum)\n  * Cation-containing antacids or laxatives\n  * Sucralfate\n  * Buffered medications\n  * Oral calcium, iron, magnesium, or zinc supplements, including multivitamins containing these polyvalent cations\n  * Dalfampridine\n  * Metformin\n  * Dofetilide\n  * Thyroid medications\n  * Corticosteroids\n  * Weight loss medications, including prescription drugs (eg, semaglutide and tirzepatide) and over-the-counter diet pills\n* Use of TAF, TDF, and\u002For FTC for the purpose of HIV PrEP or in a research study within the past 6 months.\n* Any history of exposure to cabotegravir or lenacapavir (eg, as HIV PrEP or as a participant in a research study for these drug).\n* Current use of prescrtiption or nonprescriptive medications that may have interactions with study drugs or confound the study measurements as determined by the investigators.\n* History of adverse or allergic reactions to the study drugs.\n* Daily caffeine intake \\>500 mg (about 4 cups of coffee).\n* Current smoker or user of tobacco products.\n* A change in the participant s diet and\u002For exercise regimen in the past 3 months or during the timeframe of the study period that, in the opinion of the investigator, would compromise the integrity of the data.\n* High-risk sexual activity as determined by the investigators, and\u002For inability or unwillingness to use barrier contraception during the protocol.\n* Any other condition, medication, or dietary pattern that, in the opinion of the investigators, increases risk to the participant, prevents the participant from complying with study procedures, prevents the participant from completing the study, or interferes with the interpretation of study results.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nPeople with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.\n\nObjective:\n\nTo characterize the change in plasma metabolite profile that 4 weeks of each treatment may induce in the absence of HIV infection\n\nEligibility:\n\nHealthy people aged 18 to 55.\n\nDesign:\n\nParticipants will be screened in the outpatient clinic. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.\n\nParticipants will be randomized to one of four oral treatments: Tenofovir Disoproxil Fumarate TDF\u002FViread, Tenovovir Alafenamide TAF\u002FVemlidy, Dolutegravir DTG\u002FTivicay, or both TAF and DTG taken together for 4 weeks.\n\nParticipants will have a Day 0 visit for the Lead-In Baseline visit for an exam and blood tests and continuous glucose monitor placement.\n\nParticipants will return in 2wks or Day 14\u002FWk 2 for a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density. Optional adiopse (fat) tissue biopsy in the abdomen, and optional microbiome specimen collections. Continuous glucose monitor changed. Oral once a day dose medication will be started with education.\n\nParticipants will return in 2wks or Day 28\u002FWk 4 for exam, labs, and continuous glucose monitor changed.\n\nParticipants will return in 2wks or Day 42\u002FWk 6 for final exam, labs, repeat DEXA scan, repeat adipose tissue biopsy, and microbiome specimen collections.",[28,29,30,31],"Healthy Volunteer","Weight Gain","Metabolic Effects","Integrase Strand Transfer Inhibitors",[33,34,31],"Metabolism","HIV","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":22},"2026-07-16",{"date":43,"type":22},"2030-01-31",{"name":45,"class":46},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":49,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":26,"conditions":52,"keywords":53,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":47},"100489389",{"count":21,"type":22},[25],[28,29,30,31],[33,34,31],"2026-07-01",{"date":56,"type":39},"2026-07-02",{"date":58,"type":22},"2026-07-07",{"date":43,"type":22},{"name":45,"class":46},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100549839","phase-3-a-study-of-tirzepatide-in-adolescents-with-obesity-and-weight-related-comorbidities-surmount-adolescents-2-100549839","NCT06439277","A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)","Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)","Inclusion Criteria:\n\n* Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.\n* Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.\n* Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).\n\nExclusion Criteria:\n\n* Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to\n\n  * gastric bypass\n  * sleeve gastrectomy\n  * restrictive bariatric surgery, such as Lap-Band gastric banding, or\n  * any other procedure intended to result in weight reduction.\n* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state\n* Have type 2 diabetes or have a HbA1c \\> 6.4% at screening\n* Have a history of chronic or acute pancreatitis\n* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2","12 Years","17 Years",{"count":71,"type":22},300,[73],"PHASE3","The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.\n\nParticipants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.",[76,29],"Obesity","2026-06-17",{"date":79,"type":39},"2026-06-18",{"date":81,"type":39},"2024-06-03",{"date":83,"type":22},"2030-12",{"name":85,"class":86},"Eli Lilly and Company","INDUSTRY",73,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":47},"100424854","exercise-effects-on-adipose-tissue-structure-and-function-100424854","NCT04812314","Exercise Effects on Adipose Tissue Structure and Function","LG","Inclusion Criteria:\n\n* Age: 18-40\n* Body Mass Index: 27-45 kg\u002Fm2\n* No regularly planned exercise\u002Fphysical activity for at least 6 months\n* Women must have regularly occurring menses and must be premenopausal\n\nExclusion Criteria:\n\n* Evidence\u002Fhistory of cardiovascular or metabolic disease\n* Medications known to affect lipid or glucose metabolism, or inflammation\n* Weight instability ≥ ± 6 pounds in the last 3 months\n* Tobacco or e-cigarette users\n* Women must not be pregnant or actively lactating","40 Years",{"count":97,"type":22},46,[99],"NA","Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.",[76,102,103,104,105,29],"Metabolic Syndrome","Metabolic Disease","Insulin Resistance","Weight Loss","2026-06-02",{"date":108,"type":39},"2026-06-04",{"date":110,"type":39},"2021-03-01",{"date":112,"type":22},"2030-03-01",{"name":114,"class":115},"University of Michigan","OTHER",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100635438","effects-of-high-calorie-diets-vs-high-calorie-formulas-on-weight-gain-in-children-with-congenital-heart-disease--100635438","NCT07552688","\"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease \"","\"Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease\"","Inclusion Criteria:\n\n* Children aged 1 to 5 years.\n* Diagnosed with congenital heart disease (confirmed by echocardiography).\n* Underweight (weight-for-age below the 10th percentile).\n* Medically stable and eligible for oral or enteral feeding.\n* Informed consent obtained from a parent.\n\nExclusion Criteria:\n\n* Children with genetic syndromes known to affect growth (e.g., Down syndrome).\n* Children with gastrointestinal conditions impairing nutrient absorption.\n* Children who had cardiac surgery within the last 4 weeks.\n* Presence of severe organ failure (renal, hepatic, etc.).\n* Children on parenteral nutrition.\n* Families unlikely to adhere to follow-up or dietary instructions.","1 Year","5 Years",{"count":126,"type":22},75,[99],"This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with congenital heart disease (CHD). Children with CHD often experience growth failure due to increased energy needs and feeding difficulties, which can negatively impact their recovery, development, and overall health.\n\nSeventy-five children will be randomly assigned to one of three groups: a control group receiving a standard diet, a group receiving a high-calorie diet made from energy-dense foods, and a third group receiving both the high-calorie diet and a specialized high-calorie pediatric formula. The study will measure changes in weight, appetite, feeding tolerance, and other growth indicators over an 8-week period. The goal is to determine whether enhanced nutritional support can improve weight gain and health outcomes in this high-risk population.",[29,130,131,132,133],"Body Mass Index","Pediatric Nutrition","Congenital Heart Disease","Undernutrition",[135,136,137,138],"BMI","Nutritional Status","Growth and Development","Pediatric Nursing","NOT_YET_RECRUITING","2026-04-24",{"date":142,"type":39},"2026-04-29",{"date":144,"type":22},"2026-04-17",{"date":146,"type":22},"2026-06-01",{"name":148,"class":115},"Aryan Najmadin Nasradin",2,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100431188","distal-gastric-bypass-outcome-in-revision-surgery-after-roux-en-y-gastric-bypass-100431188","NCT04894838","DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass","DISCOURSE","Inclusion Criteria:\n\n* Age 18-65 years;\n* BMI ≥40 kg\u002Fm2 or BMI ≥35 kg\u002Fm2 with obesity related comorbidity;\n* Weight regain or insufficient weight loss (EWL\\\u003C50% or TWL\\\u003C20%)15,16 following RYGB;\n* Multidisciplinary team screening at one of the bariatric centres;\n* Informed consent and willing to enter the follow-up program.\n\nExclusion Criteria:\n\n* Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation \\>50 mL, gastro-gastric fistula, gastro-jejunostomy);\n* Distalisation of RYGB is technical infeasible (judgment by surgeon);\n* Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea;\n* Severe concomitant disease (such as carcinomas and neurodegenerative disorders);\n* Pregnant women;\n* Noncompliance in follow-up or unwilling to undergo surgery;\n* Inability of reading\u002Funderstanding and filling out questionnaires.","65 Years",{"count":159,"type":22},150,[99],"This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.",[163,29],"Obesity, Morbid",[76,165,166,167],"Weight regain","Failed RYGB","Distal gastric bypass",{"date":169,"type":39},"2026-04-27",{"date":171,"type":39},"2021-05-01",{"date":173,"type":22},"2029-12",{"name":175,"class":115},"St. Antonius Hospital",8,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":184,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100499250","the-effects-of-treating-insomnia-on-behavioral-weight-loss-outcomes-in-survivors-of-breast-cancer-100499250","NCT05780814","The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer","COIN","Inclusion Criteria:\n\n* Female\n* 18 years of age or older\n* Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasive carcinoma of the breast\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Current BMI ≥ 25 kg\u002Fm2 and weight ≤ 400 lbs\n* Willing to lose 10% of body weight\n* Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast\n* Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy\u002Fimmunotherapy(\u002FHER2) human epidermal growth factor receptor 2 therapy\u002Ftargeted therapy at least 3months prior to enrollment (concomitant endocrine therapy allowed)\n* Completed all planned\u002Felective surgeries \\>4 weeks before enrollment\n* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder\n* Self-reported initial sleep onset time and\u002For wake after sleep onset (WASO) time \\> 30 minutes, \\> 3 nights\u002Fweek\n* Reports sleep problems present for ≥ 3 months\n* Insomnia Severity Index Score ≥ 9\n\nExclusion Criteria:\n\n* Serious\u002Funcontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)\n* Current use of medications that cause sleep disturbances or weight gain\u002Floss. (-) Current sedative hypnotic use\n* Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted\n* Currently enrolled or planning to enroll in a sleep treatment or weight loss program (agree not to enroll for the duration of the study) (-) Home sleep test Apnea\u002Fhypopnea Index (AHI) \\> 15\n* Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).\n* History of unstable psychiatric disorder\n* Self-reported suicidal ideation or severe depressive symptoms as determined by clinical assessment, triggered by score of ≥ 20 on the Center for Epidemiologic Studies Depression (CES-D)\n* Lactating, pregnant or plan to become pregnant in next 14 months\n* Positive urine toxicology for recreational drugs of abuse; alcohol or substance use disorder as determined by Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT294) and\u002For Structured Clinical Interview (SCID)\n* Daily smoker\u002Fnicotine user\n* Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the patient's full compliance with or completion of the study","FEMALE",{"count":186,"type":22},250,[99],"The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.",[190,191,29],"Breast Cancer","Insomnia",[193,194,195,196,197,198],"women","breast cancer","weight gain","weight loss","insomnia","sleep","2026-02-19",{"date":201,"type":39},"2026-02-23",{"date":203,"type":39},"2024-02-01",{"date":205,"type":22},"2028-12-31",{"name":207,"class":115},"Johns Hopkins University",4,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":157,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100625797","focused-echocardiography-for-primary-care-physicians-100625797","NCT07427303","Focused Echocardiography for Primary Care Physicians","CLINICAL FEASIBILITY OF ULTRAPORTABLE CARDIAC ULTRASOUND PERFORMED IN THE GENERAL PRACTITIONER'S OFFICE TO IDENTIFY CARDIOVASCULAR ABNORMALITIES","UPCOMING","Inclusion Criteria:\n\n* Men and women aged 65 or older with no cardiac symptoms and presenting with a treated or untreated cardiovascular risk factor (hypertension and\u002For diabetes and\u002For dyslipidemia) or\n* Adult men and women presenting with one of the following signs:\n\n  * Stage I-II exertional dyspnea\n  * Lower limb edema\n  * Unexplained fatigue\n  * Weight gain\n  * Unexplained cough\n  * History of carpal tunnel surgery (search for signs of myocardial infiltration by cardiac amyloidosis)\n\nExclusion Criteria:\n\n* Patients with arrhythmia or ventricular or supraventricular hyper excitability.\n* Symptomatic patients:\n\n  * exertional dyspnea (NYHA \\>2)\n  * palpitations\n  * malaise\n  * chest pain\n* Obese individuals with a BMI \\>35\n* Patients with breast implants\n* Patients under guardianship, conservatorship, or legal protection\n* Patients without health insurance coverage or equivalent\n* Patients known to have heart disease\n* Patients who have had a cardiology consultation within the last 5 years\n* Subjects with known heart disease, whether monitored or not.\n* Known valvular heart disease (whether monitored or not)\n* Known coronary artery disease (whether monitored or not)","120 Years",{"count":71,"type":22},[99],"Our society is characterized by a steady improvement in the standard of living of its inhabitants, which is reflected, among other things, in improved healthcare and quality of life (longer life expectancy, lower infant mortality, treatment of chronic diseases, cancer plan). Many factors contribute to this, but technological innovations and therapeutic advances are the main ones. This positive overall picture should not obscure the fact that there are significant regional disparities.\n\nFor more than 15 years, the former Lower Normandy region (Calvados, Manche, and Orne), like many other regions in France, has been marked by increasingly complex access to healthcare, whether for primary care or for so-called specialty disciplines. This situation is gradually leading to the creation of medical deserts. There are many reasons for this (numerus clausus, sociological changes, urbanization of young practitioners, attraction of small rural towns by medium-sized cities), which are chronic and have no clearly identified solution.\n\nThis situation complicates patient care and, in some cases, represents a major public health challenge, such as in the treatment of heart failure (HF), which affects more than one million people in France, or 2.3% of the adult population. For 2.3 times more deaths each year than strokes and five times more than myocardial infarctions.\n\nSome healthcare innovations can reduce the consequences of these areas of stress. In the field of cardiology, recent initiatives based on the creation of specialized cardiology and telemedicine care teams have been proposed. In primary care, point-of-care solutions enable many tests to be performed on an outpatient basis. Imaging plays a central role in patient care, and ultrasound is often the first-line modality in cardiology. Technological innovations in this field have made it possible to miniaturize ultrasound machines to such an extent that some of them can now be considered POCUS (point-of-care ultrasound). Their reduced manufacturing costs, combined with the maturity of the technique, make it possible to offer simplified acquisition protocols adapted to specific questions, known as targeted clinical ultrasound.\n\nThis simplification\u002Fminiaturization of ultrasound equipment has facilitated the spread of this technique outside the field of cardiology and now allows for its use by general practitioners close to patients, specifically for screening purposes. Many diseases would benefit from early screening in order to reduce hospitalizations, mortality, and societal costs. In cardiology, this approach remains difficult because the majority of patients admitted to healthcare facilities have already developed the disease. HF is characterized by an initial silent phase which, if left untreated, inevitably leads to complications and death. It is responsible for 200,000 hospitalizations per year in France, causing the deaths of 70,000 people. Certain signs, grouped under the French acronym EPOF, appear early on and can be warning signs, but they are often vague and unfamiliar to the general public. This fact is well illustrated by the results of a survey conducted by the Heart Failure and Cardiomyopathy Group (GICC) of the French Society of Cardiology (SFC) in 2017 (5,000 subjects representative of the French population aged 18 to 80). This survey noted that two-thirds of subjects presenting four of these signs (EPOF) had not consulted a cardiologist in the 12 months prior to the questionnaire. In the majority of cases, these patients, whether asymptomatic or paucisymptomatic (EPOF), have morphological and functional abnormalities of the heart, which are the first step toward more severe complications and can be detected by cardiac echocardiography.\n\nThere is currently a favorable alignment between echocardiography as a public health need (early detection of conditions that can lead to heart failure) and frontline practitioners (general practitioners). This alignment could lead to the definition of new practices and a new care pathway. While echocardiography is technically feasible in a general practitioner's office, its implementation remains to be evaluated (HAS report). This report emphasizes the lack of data in the literature to identify use cases and clinical impact in general medicine in France.",[222,223,224,225,226,227,29],"Age 65 and Older","Cardiac Risk Factors","Dyspnea; Cardiac","Oedema","Fatigability","Cough","2026-02-16",{"date":201,"type":39},{"date":231,"type":22},"2026-03-01",{"date":233,"type":22},"2027-05-31",{"name":235,"class":115},"University Hospital, Caen",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":47},"100617967","phase-2-incretin-microdosing-for-cardiometabolic-health-in-people-with-hiv-100617967","NCT07325500","Incretin Microdosing for Cardiometabolic Health in People With HIV","Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial","REINFORCE","Inclusion Criteria:\n\n* Confirmed human immunodeficiency virus type 1 (HIV-1)\n* On antiretroviral therapy (ART) for greater than or equal to 24 weeks prior to entry and no change in regimen in the 12 weeks prior to entry or planned change for the study duration\n* HIV-1 ribonucleic acid (RNA) \\\u003C200 copies\u002FmL at screening\n* BMI greater than or equal to 30 kg\u002Fm2 or greater than or equal to 27 kg\u002Fm2 if also with greater than or equal to 1 weight-related comorbidity\n* If taking anti-inflammatory or blood-pressure-\u002Flipid-\u002Fglucose-lowering medications, no change in dose for greater than or equal to 12 weeks prior to entry and no plans to dose escalate for the study duration\n* All participants must be willing and able to provide written informed consent and undergo all required study procedures\n\nExclusion Criteria:\n\n* Weight greater than or equal to 400 pounds \\[due to dual X-ray absorptiometry (DXA) machine limitations\\] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry\n* Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded)\n* Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period\n* Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period\n* Active eating disorder\n* Use of human growth hormone, tesamorelin or anabolic steroids \\\u003C12 weeks prior to entry, unless on a stable dose for \\>24 weeks prior to entry, or plans to start any of these medications while on study\n* Active, severe delayed gastric emptying\n* Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study\n* Known retinopathy\n* Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n* Untreated, poorly controlled or previously undiagnosed thyroid disease\n* Chronic pancreatitis\n* Known allergy\u002Fsensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA)\n* Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) \\\u003C0.5 or \\>10 milli-international units per liter (mIU\u002FL) at screening\n* Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements\n* Pregnancy, nursing or plans for either during the study period\n* Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period\n* Current serious illness requiring systemic treatment and\u002For hospitalization, in the opinion of site investigator",{"count":245,"type":22},30,[25],"The objectives of this study are as follows:\n\nPrimary Objective\n\n* To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs. no additional drug following induction therapy.\n\nSecondary Objectives\n\n* To evaluate the tolerability of semaglutide microdosing in adults with HIV.\n* To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy.",[29],[250,34,251],"semaglutide","obesity","2026-02-13",{"date":254,"type":39},"2026-02-18",{"date":256,"type":39},"2026-02-12",{"date":258,"type":22},"2029-06-30",{"name":260,"class":115},"The University of Texas Health Science Center, Houston",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":184,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":47},"100439311","grocery-delivery-and-healthy-weight-gain-among-low-income-pregnant-young-women-100439311","NCT05000645","Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women","Inclusion Criteria:\n\n* Gestational age ≤ 20 weeks\n* Text message capability\n* Healthy singleton pregnancy\n* Nulliparous\n* Consume sugar sweetened beverages (SSBs)\n* Living within delivery zone of a grocery delivery service\n\nExclusion Criteria:\n\n* Non-English speaking\n* Participants who live at the same address\n* Physical, mental, or cognitive handicaps that prevent participation\n* High risk pregnancy requiring specialized care (including pre-existing diabetes)","14 Years","26 Years",{"count":270,"type":22},570,[99],"This project will increase knowledge about how a simple intervention, grocery delivery, impacts weight gain and diet among low-income pregnant young women. Results can then be used to support other pregnant young women.",[274,29],"Pregnancy",[276,277,278,279,280],"WIC","Low-income","Diet","Sugar sweetened beverages","Grocery delivery","2026-02-11",{"date":283,"type":39},"2026-02-17",{"date":285,"type":39},"2021-12-08",{"date":287,"type":22},"2027-04-30",{"name":114,"class":115},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":297,"maxAge":157,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":47},"100607562","time-restricted-eating-for-weight-loss-maintenance-2-100607562","NCT07190170","Time Restricted Eating for WeIght LoSs MainTenance-2","Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss","TWIST-2","Inclusion Criteria:\n\n* ≥5% non-surgical weight loss in the last 3 mos;\n* current BMI 20.5-45 mg\u002Fkg2;\n* between the ages 25 to 65 years old;\n* own a smartphone or willing to use a smartphone if provided for self-monitoring. For in-person screening, eligible participants will provide signed informed consent and have their temporal eating patterns measured.\n\nExclusion Criteria:\n\n* pregnant, trying to get pregnant or breastfeeding;\n* previous or planned bariatric surgery;\n* previous or current history of eating disorder;\n* ongoing participation in another weight-management research study;\n* continued participation in a weight loss program other than the proposed study;\n* currently on appetite suppressants;\n* currently following intermittent fasting; or skipping meals;\n* eating window \\\u003C11h 59min\u002Fday;\n* perform overnight shift work more than once a week;\n* work that includes travel across one or more time zones;\n* taking medications that affect body weight or would preclude TRE;\n* unable or unwilling to provide informed consent;\n* unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);\n* unwilling to accept randomization assignment;\n* unable to log at least 2 meals into the smartphone app for 70% (\\~20 days) during of the run-in period;\n* have type 1 or type 2 diabetes, or other conditions that would preclude restricted eating windows;\n* narcolepsy,\n* \\>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria);\n* is non-English speaking (the mCC app is currently only available in English).","25 Years",{"count":299,"type":22},110,[99],"The TWIST 2.0 Study is a 12-month, 2-arm RCT in adults with recent weight loss. We will examine the efficacy of TRE on weight (Aim 1a) and fat mass (Aim 1b) regain, and describe changes in subjective appetite following a mixed-meal tolerance test (Exploratory).",[105,29,303],"Weight Loss Maintenance",[251,305,306],"time-restricted eating","weight-loss maintenance","2025-12-23",{"date":309,"type":39},"2025-12-26",{"date":311,"type":39},"2025-10-01",{"date":313,"type":22},"2028-01-01",{"name":315,"class":115},"NYU Langone Health",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":16,"sex":17,"minAge":322,"maxAge":68,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":324,"briefSummary":325,"conditions":326,"keywords":331,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":149},"100515529","the-sweet-kids-study-stevia-on-weight-and-energy-effect-over-time-100515529","NCT05992688","The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)","Inclusion Criteria\n\n* Age 8-12 years\n* Normal weight: BMI percentile ≥5th to \\\u003C85th\n* Excessive weight: BMI percentile ≥ 85th and \\\u003C140% of the 95th percentile or BMI ≥35 to \\\u003C40 kg\u002Fm2\n* Current consumption of sugar sweetened beverages (≥2 times \u002Fwk)\n* Low consumption of non-nutritive sweeteners (≤ 3 time\u002Fwk)\n* Willingness to consume experimental products Exclusion Criteria\n* Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg\u002Fm2)\n* Dislike of experimental beverage taste (assessed at initial visit)\n* Asthma that requires daily use of inhalers to keep symptoms under control.\n* Asthma that requires use of rescue inhalers (e.g., albuterol) \\>2 days per week\n* Exercise induced asthma.\n* Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).\n* Attention deficit hyperactivity disorder (ADHD) currently under medication.\n* Oppositional defiant disorder (ODD).\n* Epilepsy.\n* Cancer.\n* Chronic kidney disease.\n* Endocrine disorder (e.g., hypothyroidism and growth hormone deficiency).\n* Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)\n* Bleeding disorders (e.g., hemophilia)\n* Chronic infections (e.g., HIV, hepatitis B, hepatitis C).\n* Mental health disorders (e.g., depression and anxiety).\n* Type 2 and type 1 diabetes mellitus.\n* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.\n* If, during the screening or consent process, the parent or child expresses refusal to have blood drawn. However, participants may remain in the study if after initially agreeing to the blood draw and enrolling they change their minds and choose not to allow blood draws or if blood draws are unsuccessful.\n* Dislike of study products assessed at initial visit.\n* Fasting glucose ≥126 mg\u002Fdl at enrollment.\n* Fasting A1C ≥6.5% at enrollment\n* Less than 2 months since completion of antibiotics","8 Years",{"count":159,"type":22},[99],"This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.\n\nThe main purpose of the study is to evaluate if stevia has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.",[327,328,29,329,330],"Adiposity","Insulin Sensitivity","Blood Pressure","Lipoproteins",[332],"Cardiometabolic health","2025-12-16",{"date":335,"type":39},"2025-12-22",{"date":337,"type":39},"2023-09-19",{"date":339,"type":22},"2026-11-30",{"name":341,"class":115},"Arkansas Children's Hospital Research Institute",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":47},"100555378","exercise-brain-activity-and-weight-maintenance-100555378","NCT06511310","Exercise, Brain Activity, and Weight Maintenance","Effects of Exercise Training on Brain Activity and Its Relation to Weight Maintenance and Appetite Regulation","Inclusion Criteria:\n\n* Age 18-70 years\n* Body mass index (BMI) \\>19 kg\u002Fm2 and body weight\\\u003C 250kg\n* Participants must have experienced a clinically significant weight regain, defined as over 10% of their maximum weight lost, within 1 to 5 years following their bariatric surgery. They will be asked to self-report their weight loss history. Participants must also provide the operative report from their bariatric surgery for reference.\n* In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations\n* Willing to adhere to the protocol requirements for the duration of the study\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Peripheral neuropathy with insensate feet\n* Recent blood donation within the last 2 months\n* Use of beta-blockers\n* Current pregnancy or breastfeeding\n* Active Heart or lung disease\n* Severe hypertension (systolic \\>160 mmHg or diastolic \\>90 mmHg)\n* Inability to exercise for any reason\n* Any known contraindication to exercise testing based on current ACSM guidelines\n* MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body\n* Known presence of a structural brain lesion (e.g. tumor, cortical infarct)\n* Presence of another neurologic disorder, which could impact findings (e.g. multiple sclerosis)\n* History of cardiovascular disease, stroke, congestive heart failure\n* Active hematological, renal, pulmonary or hepatic disorders\n* Active treatment for cancer\n* A history of active alcohol or substance abuse\n* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol\n* History of claustrophobia and inability to tolerate an MRI\n* Body weight \\>250kgr and largest body diameter of 70cm as there is a certain weight and diameter limit of the MRI scanner\n* Unwilling or unable to return for study visits, undergo neuropsychological testing and MRI imaging\n* Left-handedness","70 Years",{"count":351,"type":22},15,[99],"This study aims to explore how HIIT influences brain function, neural and molecular pathways related to weight control, setting the stage for future obesity intervention research.",[76,29,355,356],"Bariatric Surgery Candidate","Appetitive Behavior","2025-08-27",{"date":359,"type":39},"2025-09-04",{"date":361,"type":22},"2025-09-15",{"date":363,"type":22},"2027-07-01",{"name":365,"class":115},"Joslin Diabetes Center",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":16,"sex":17,"minAge":373,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":382,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":47},"100381894","effect-of-kangaroo-care-on-test-weighing-100381894","NCT04252547","Effect of Kangaroo Care on Test Weighing","The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants","Inclusion Criteria:\n\n\\- Agreeing to participate in the study for parents.\n\nThe inclusion criteria for infants were as follows;\n\n* Attaining to oral feeding by the physician in the neonatal intensive care unit\n* Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle\n* Being at 32-39+6 postmenstrual week during the time they are included in the study\n* Having body weight of 1500 grams and above\n* Being breastfed at least once\n* Having no health problems other than being preterm\n\nExclusion Criteria:\n\nThe exclusion criteria for infants were as follows;\n\n* Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases\n* Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.)\n* Receiving oxygen support","32 Weeks","40 Weeks",{"count":97,"type":22},[99],"The study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.",[379,29,380,381],"Kangaroo Care","Oxygen Saturation","Heart Rate",[383,384,385,386,387],"kangaroo care","test weighing","Heart rate","oxygen saturation","preterm infants","2025-04-29",{"date":390,"type":39},"2025-05-02",{"date":392,"type":39},"2024-06-09",{"date":394,"type":22},"2026-01-09",{"name":396,"class":115},"Istanbul University - Cerrahpasa",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":16,"sex":17,"minAge":405,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":408,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":47},"100518251","phase-2-a-novel-obesity-prevention-program-for-high-risk-infants-in-primary-care-100518251","NCT06028113","A Novel Obesity Prevention Program for High-Risk Infants in Primary Care","A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial","THRIVE","Inclusion Criteria:\n\n* born 2500 grams or greater\n* delivery occurring between 37 and 42 weeks gestation\n* English speaking\n* infant receiving care provided at our pediatric primary care setting\n* from a racial \u002F ethnic minority group (i.e., non-white, or Hispanic or Latinx) and\u002For economically marginalized background (i.e., household income at or below 138% of federal poverty level; qualifying for Medicaid)\n\nExclusion Criteria:\n\n* care in the Neonatal Intensive Care Unit (\\>7 days)\n* infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip\u002Fpalate, metabolic disease)\n* infant exposure to illicit drugs in utero \\[with the exception of tetrahydrocannabinol (THC)\\]\n* diminished or impaired caregiver cognitive functioning\n* family intent to move from the area within 1 year","1 Day",{"count":407,"type":22},144,[25],"The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic\u002FLatinx) and\u002For who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are:\n\n* 1\\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and\u002For families who are economically marginalized?\n* 2\\) Will it prevent rapid weight gain during infancy?\n\nParticipants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.",[76,411,29,412],"Obesity, Childhood","Weight Gain Trajectory",[414,415,416,417,418,419,198,420],"obesity prevention","infancy","integrated primary care","integrated behavioral health","responsive parenting","responsive feeding","soothing","2025-03-03",{"date":423,"type":39},"2025-03-05",{"date":425,"type":39},"2023-10-05",{"date":427,"type":22},"2026-01-30",{"name":429,"class":115},"Children's Hospital Medical Center, Cincinnati",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":16,"sex":437,"minAge":18,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":441,"phases":4,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":47},"100514717","weight-changes-among-martinican-prisoners-100514717","NCT05982132","Weight Changes Among Martinican Prisoners","NUTRI-LAJÔL","Inclusion Criteria:\n\n* all men newly incarcerated in martinican jail during inclusion period\n* age between 18 and 44 years old\n* having given his consent\n\nExclusion Criteria:\n\n* female\n* 44 years old and up\n* not understanding or speaking French or English","MALE","44 Years",{"count":440,"type":22},227,"OBSERVATIONAL","Assessment of body weight change among prisoners in Martinique between admission in jail and 3 months later expressed as a percentage of admission weight. Intensity of physical activities, nutrition intakes and psychological state are also studied to describe associated factors to body weight change.",[29,105],[445,446,447,448,449],"Prisoners","Body weight","Male","French West Indies","Epidemiology","2025-02-20",{"date":452,"type":39},"2025-02-24",{"date":454,"type":39},"2023-01-11",{"date":456,"type":22},"2025-08",{"name":458,"class":115},"University Hospital Center of Martinique",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":184,"minAge":18,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":149},"100572564","healthypregnancy---digital-support-for-pregnant-women-with-a-bmi-at-25-or-above-bmi25-100572564","NCT06734910","HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)","Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* BMI 25 or above at first prenatal visit\n* Age 18 years or older\n* Singleton pregnancy\n* Appropriate Danish or English language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Age under 18 years\n* Multiple pregnancy\n* Gestational age above 16+0 at inclusion\n* Alcohol or drug abuse\n* Being diagnosed with eating disorder, schizophrenia, psychosis, or similar\n* Diagnosis of malformations or chromosomal disorder in the fetus\n* Conditions that lead to recommendations against physical activity during pregnancy e.g., cerclage.","60 Years",{"count":468,"type":22},450,[99],"The study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study.\n\nThe investigators hypothesise that access to a digital care guide focusing on diet, exercise and mental support, will support a reduced weight gain in pregnancy and improve the mental wellbeing of the participants.",[472,29],"Pregnancy Related",[274,474,475,476,477,278],"Gestational weight gain","Mental well-being","Digital interventions","Physical activity","2024-12-10",{"date":480,"type":39},"2024-12-16",{"date":482,"type":39},"2024-09-09",{"date":484,"type":22},"2027-06",{"name":486,"class":487},"Center for Clinical Research and Prevention","NETWORK",{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":184,"minAge":18,"maxAge":157,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":4},"100561448","phase-4-evaluating-the-effects-of-adjunctive-aripiprazole-on-weight-and-metabolic-outcomes-in-females-100561448","NCT06590298","Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females","Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Females aged 18-65 years diagnosed with a mental health condition necessitating antipsychotic treatment.\n* Diagnosis of Schizophrenia or Schizoaffective Disorder\n* On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month\n* Willingness to comply with the study protocol.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Severe medical conditions impacting weight or metabolism.\n* Previous intolerance or contraindications to Aripiprazole.\n* Non-compliant with prescribed medications\n* Mental Retardation\n* Participant with an eating disorder\n* Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.\n* Diagnosis of Hyper or Hypothyroidism; Evidence of thyroid dysfunction as evidenced by serum thyroid function tests (i.e Thyroid Stimulating Hormone and -Free Thyroxine (fT4) levels \\&gt; 10 % above or below the limits of the normal range Use of any medication for weight loss within the past one month to the study entry\n* Clinically significant abnormalities in physical examinations, ECG or lab assessments",{"count":496,"type":22},600,[498],"PHASE4","Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gain, are a common and challenging side effect of many antipsychotics. Aripiprazole, an atypical antipsychotic, has shown promise in mitigating this adverse effect when used in combination with other antipsychotic medications.",[501,102,29],"Psychosis","2024-09-06",{"date":504,"type":39},"2024-09-19",{"date":506,"type":22},"2024-09-15",{"date":508,"type":22},"2025-04-10",{"name":510,"class":115},"Universiti Putra Malaysia",{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":441,"phases":4,"briefSummary":521,"conditions":522,"keywords":529,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":544},"100387864","hiv-heart-aging-study-100387864","NCT04330287","HIV-HEART Aging Study","A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 15 Year Follow up","HIVH","Inclusion Criteria:\n\n* Age \\> 18 years\n* Known HIV-infection\n* Signed informed consent\n\nExclusion Criteria:\n\n* Acute cardiovascular disease\n* Unstable hemodynamic status in the three weeks before inclusion\n* Pregnancy",{"count":520,"type":22},2000,"The HIV\u002FHEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1858 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.",[523,524,525,526,527,528,29],"HIV Infections","Coronary Disease","Myocardial Infarction","HIV Encephalopathy","Aging","Heart Failure",[34,530,531,527,528,532,533,534,195],"AIDS","Antiretroviral therapy","coronary heart desease","myocardial infarction","HIV-associated neurocognitive disorders","2024-07-29",{"date":537,"type":39},"2024-07-30",{"date":539,"type":39},"2020-05-11",{"date":541,"type":22},"2025-12-31",{"name":543,"class":115},"University Hospital, Essen",5,{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":466,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":4},"100553611","food-replacement-on-weight-control-in-overweight-volunteers-100553611","NCT06488339","Food Replacement on Weight Control in Overweight Volunteers","Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers","Inclusion Criteria:\n\n* Age 18-60 years\n* Body mass index more than 23 kg\u002Fm2\n* No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases\n* Wiling to attend the study\n\nExclusion Criteria:\n\n* Allergic to protein, grains, guar gum\n* Take medicine, supplement, herbal substance for weight control within 1 month\n* During intermittent fasting\n* Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs\n* Cushing syndrome's\n* Pregnancy and lactation",{"count":553,"type":22},60,[99],"Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.",[29],"2024-06-28",{"date":559,"type":39},"2024-07-05",{"date":561,"type":22},"2024-07-15",{"date":563,"type":22},"2025-05-15",{"name":565,"class":115},"Chulalongkorn University",{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":582,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":47},"100498851","sleep-and-metabolism-100498851","NCT05775627","Sleep and Metabolism","Uncovering Sleep and Circadian Mechanisms Contributing to Adverse Metabolic Health","SAM","Inclusion Criteria:\n\n* Between 18 and 40 years of age\n* Drug free\n* Established disease-free status\n\nExclusion Criteria:\n\n1. Dietary restrictions\n\n   Participants must not have dietary restrictions that could systematically bias their macronutrient intake. The following will exclude participants from enrolling in the study based on their diet:\n   * Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream)\n2. Body Composition\n\n   A body mass index (BMI) of 18.5\\\u003C \\[BMI\\] \\\u003C 25 kg\u002Fm2 and a waist circumference \\\u003C94\u002F80cm.\n3. Psychiatric\u002Fpsychological suitability\n\n   Each participant will undergo a structured interview (Mini International Neuropsychiatric Interview) with a qualified OHSU physician. This physician will supervise the administration and scoring of a Beck Depression Inventory II (BDI-II) questionnaire for each potential participant. The following will exclude individuals from participating based on their psychiatric or psychological evaluation:\n   * Individuals with evidence of psychopathology on the BDI-II, or in a structured clinical interview with the physician\n   * A history of severe psychiatric illnesses\n   * Alcoholism\n   * Drug dependency\n   * Major depression\n   * Manic depressive illness\n   * Schizophrenic disorders\n   * Panic disorder\n   * Generalized anxiety disorder\n   * Post-traumatic stress disorder\n   * Agoraphobia\n   * Claustrophobia\n   * Paranoid personality disorder\n   * Schizoid personality disorder\n   * Schizotypal personality disorder\n   * Borderline personality disorder\n   * Antisocial personality disorder.\n   * History of using antidepressant medication\n   * History of using neuroleptic medication\n   * History of using tranquilizers\n4. Drug\u002Falcohol use\n\n   Volunteers must be drug-free (including caffeine, nicotine, alcohol and herbal medications) for the entire duration of the outpatient and in-laboratory study period, with no history of drug or alcohol dependency. All participants must be:\n   * Current non-smokers, and are required to have a history of less than 5 'pack years' of smoking\n5. Medication\u002Fdrug use\n\n   Volunteers must not be taking any prescribed medications or over the counter medications, with an exception for birth control.\n6. Prior shift work\n\n   For stability of endogenous circadian rhythmicity, volunteers must have no history of the following 1 year prior to the study:\n   * Working irregular day and night hours\n   * Regular night work\n   * Rotating shift work f\n   * Not have traveled more than 1 time zone during 3 months prior to the study\n7. Chronobiologic and sleep disorders\n\n   * Hypernychthemeral sleep\u002Fwake cycle\n   * Delayed sleep phase syndrome (wake time \\> 2 hours later than desired or habitually after 10:00 AM)\n   * Advanced sleep phase syndrome (wake time \\> 2 h earlier than desired or habitually before 5:00 AM)\n   * Narcolepsy\n   * Sleep apnea (apnea index \\>15)\n   * Insomnia (sleep complaint by history or polygraphically recorded sleep efficiency \\\u003C 80%)\n   * Hypersomnia\n   * Periodic Limb Movement (PLMS) (PLMS index \\>15)\n   * Nocturnal Paroxysmal Dystonia\n   * REM-sleep behavior disorder\n   * Nocturnal Enuresis; (self-report and first night in the laboratory)\n   * Obstructive sleep apnea (apnea\u002Fhypopnea index \\>5\u002Fh as determined by at-home monitoring)\n   * The investigators will also exclude individuals with extreme chronotype using the Horne-Ostberg Morningness\u002FEveningness questionnaire (i.e., the Owl\u002FLark Questionnaire)\n8. Diseases of the Cardiovascular System\n\n   * Hypertension (systolic blood pressure \\> 140 or diastolic blood pressure \\> 90)\n   * Heart failure\n   * Cardiomyopathy\n   * Cor pulmonale\n   * Ischemic heart disease\n   * Valvular heart disease\n   * History of heart transplantation\n   * Cardiac tumors\n   * Pericardial disease\n9. Metabolic Syndrome\n\n   Following American Heart Association cutoffs, participants who have, in addition to abdominal fat (obese exclusion criteria), two or more of these factors will be excluded from the study:\n   * HDL cholesterol of less than 40 mg\u002FdL in men or less than 50 mg\u002FdL in women\n   * Systolic blood pressure \\>135 mmHg or diastolic blood pressure \\>85 mmHg\n   * Fasting blood glucose ≥ 100 mg\u002FdL\n   * Triglycerides ≥ 150 mg\u002FdL\n10. Pre-Diabetes\u002FDiabetes\n\n    For participants who have a fasting blood glucose level of ≥ 100 mg\u002FdL the investigators will measure hemoglobin A1c to exclude for diabetes (HbA1c\\>5.7%).\n11. Hypertension\n\n    An upper cut off of 140\u002F90 mmHg during an office blood pressure measure will be used as an exclusion criterion. After 5 minutes of rest in a seated position, blood pressure will be measured 3 times, taken 1 minute apart. The average will be used to confirm eligibility criteria. Current or history of beta blocker use will also be exclusionary.\n12. Disorders of the Respiratory System\n\n    * Asthma\n    * Cystic fibroses\n    * Chronic bronchitis\n    * Emphysema\n    * Airway obstruction\n    * Interstitial lung diseases\n    * Pulmonary hypertension\n    * Lung neoplasms\n    * ARDS\n13. Disorders of the Kidney and Urinary Tract\n\n    * Acute or chronic renal failure\n    * History of renal transplantation\n    * Tubulointerstitial diseases of the kidney\n    * Urinary tract obstruction\n    * Tumors of the urinary tract\n14. Infectious Diseases\n\n    * Infective endocarditis\n    * HIV infection\n    * Sexually transmitted diseases \\[e.g., syphilis (including congenital syphilis and its sequelae), gonorrhea\\],\n    * Urinary tract infection\n    * Osteomyelitis\n    * Brucellosis\n    * Toxoplasmosis,\n    * Tuberculosis\n    * Leptospirosis\n    * Lyme disease\n    * Mononucleosis\n    * Hepatitis\n    * Parasitic infections such as malaria, toxoplasmosis, giardiasis, schistosomiasis, leishmaniasis\n15. Disorders of the Gastrointestinal System\n\n    * Esophagitis\n    * Peptic ulcer and gastritis\n    * Neoplasms of the esophagus, stomach or bowel\n    * Disorders of absorption\n    * Inflammatory bowel disease\n    * Diseases of the small and large intestine\n    * Acute appendicitis\n    * Cirrhosis or neoplasms of the liver\n    * History of liver transplantation\n    * Diseases of the gallbladder and bile ducts\n    * Pancreatic disease\n16. Disorders of the Immune System, Connective Tissue and Joints\n\n    * AIDS\n    * Systemic lupus erythematosus\n    * Rheumatoid arthritis\n    * Scleroderma\n    * Ankylosing spondylitis\n    * Vasculitis\n    * Sarcoidosis\n17. Disorders of the Hematopoietic System\n\n    * Anemia\n    * Leukemia\n    * Myeloproliferative diseases\n    * History of bone marrow transplantation\n18. Neoplastic Diseases\n\n    * Lymphoma\n    * Carcinoma\n    * Melanoma\n    * Any other neoplastic diseases\n19. Endocrine and Metabolic Diseases\n\n    * Thyroid disease\n    * Addison's Disease\n    * Cushing's Syndrome\n    * Aldosteronism\n    * Hypoaldosteronism\n    * Pheochromocytoma\n    * Disorders of sexual differentiation that require hormone supplementation that may alter body weight\n    * Disorders of neuroendocrine regulation\n    * Diseases of the anterior pituitary and hypothalamus\n    * Hemochromatosis porphyria\n    * Wilson's Disease\n    * Glycogen storage diseases\n    * Diseases of the parathyroid gland\n    * Metabolic bone disease\n    * Disorders of phosphorus or magnesium metabolism\n    * Paget's Disease\n20. Neurologic Disorders\n\n    * Epilepsy and disorders of consciousness\n    * Dementia\n    * Amnesic disorders\n    * Neoplastic diseases of the central nervous system\n    * Demyelinating diseases\n    * Parkinson's Disease\n    * Muscular dystrophy\n    * Myasthenia gravis\n    * Periodic paralysis\n    * Dermatomyositis\n    * Polymyositis\n    * Infections of the nervous system\n    * Stroke\n    * History of transient ischemic attacks\n    * Hydrocephalus\n    * Tumors of the pituitary gland\n    * Pinealoma\n    * Intervertebral disc disease\n    * Ataxia\n    * Gilles de la Tourette Syndrome\n    * Huntington's Disease\n    * Tardive dyskinesia\n    * History of recurrent migraine headaches\n    * Neuromuscular disease.\n21. Subjects must not be currently participating in another research study that would influence their safe participation in our study. Subjects must not be participating in a research study in which they do the following:\n\n    * Ingest experimental medication\n    * Give blood samples",{"count":575,"type":22},20,[99],"The goal of this study is to uncover sleep and circadian mechanisms contributing to adverse metabolic health. The protocol is a 21 day (7 outpatient days, 14 inpatient days) mechanistic randomized-crossover study designed to identify the impact of chronic sleep restriction and circadian timing, independently and in combination on energy metabolism and identify the independent and combined effects on glucose tolerance.",[579,76,580,29,581],"Sleep Deprivation","Glucose Intolerance","Food Selection",[583,251,584,195,585,586,587],"sleep restriction","glucose intolerance","circadian timing","ad libitum","food selection","2024-04-02",{"date":590,"type":39},"2024-04-03",{"date":592,"type":39},"2023-12-01",{"date":594,"type":22},"2027-06-30",{"name":596,"class":115},"Oregon Health and Science University",{"id":598,"slug":599,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":604,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":610,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":4},"100538167","phase-4-semaglutide-24mg-for-low-responders-after-bariatric-surgery-100538167","NCT06287307","Semaglutide 2.4mg for Low Responders After Bariatric Surgery","SEABAR","Inclusion Criteria:\n\n* BMI before surgery was ≥ 35.0 kg\u002Fm2\n* Patient is treated with group consultation at the NOK\n* Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)\n* Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.\n\nExclusion Criteria:\n\n* Gastropareses or gastro-intestinal complaints after bariatric surgery\n* Type 1 or type 2 diabetes and\u002For diabetic retinopathy\n* Decreased renal function (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Liver failure (all)\n* Congestive heart failure or angina pectoris NYHA class III and IV\n* Malignancy in history\n* Pancreatitis (in history)\n* (expected) Pregnancy \u002F breast-feeding\n* Inflammatory Bowel Disease\n* Thyroid malignancy in history\n* Use of warfarin or other coumarin derivates","75 Years",{"count":606,"type":22},152,[498],"In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and\u002For tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.",[76,163,29],[76,611,612,613,105],"Semaglutide","GLP-1","Bariatric Surgery","2024-02-22",{"date":616,"type":39},"2024-03-01",{"date":618,"type":22},"2024-05",{"date":620,"type":22},"2026-09",{"name":622,"class":115},"Zuyderland Medisch Centrum",{"id":624,"slug":625,"hasResults":11,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":11,"sex":17,"minAge":630,"maxAge":373,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":149},"100404035","growth-of-preterm-infants-fed-a-infant-milk-formula-containing-high-versus-low-amounts-of-beta-palmitate-100404035","NCT04541095","Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate","A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate","Inclusion Criteria:\n\n* gestational age between 24 and 32 weeks of gestation at enrollment,\n* birth weight greater than 750 grams,\n* singleton or twin birth (no triplet or higher),\n* fraction of inspired oxygen lower than 0.60 at enrollment,\n* feasible enteral feeding,\n* cardiovascular stable condition,\n* informed consent form signed by at least one parent or legal guardian.\n\nExclusion Criteria:\n\n* congenital malformations, genetic, metabolic and endocrine disorders,\n* suspicious infection at enrollment,\n* intrauterine growth restriction (\\\u003C10th centile) at enrollment,\n* maternal diabetes requiring insulin therapy,\n* neonatal asphyxia.","24 Weeks",{"count":159,"type":22},[99],"The aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX\\_IMF) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (ST\\_IMF). Own mother milk (OMM) fed infants will serve as reference group.",[29],[636,637,638,639,640],"Growth","Preterm Infants","Beta-palmitate","Infant formula","Human milk","2023-01-20",{"date":643,"type":39},"2023-01-25",{"date":645,"type":39},"2023-01-16",{"date":647,"type":22},"2027-12",{"name":649,"class":115},"Ospedali Riuniti Ancona"]