[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obesitytherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obesitytherapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,82,112,151,198,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100594629","phase-3-brain-plasticity-and-glp-1-receptor-agonist-treatment-for-obesity-100594629",false,"NCT07021937","Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity","Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial","PLASTIC","Inclusion Criteria:\n\n* English-speaking\n* male or female (sex assigned at birth)\n* 12-18 y\u002Fo with obesity (BMI\\>120% of the 95th %ile)\n* 30-45 y\u002Fo with obesity (BMI\\>35 kg\u002Fm2)\n\nExclusion Criteria:\n\n* treated with glucagon-like peptide-1 (GLP-1) agonists (e.g., exenatide, liraglutide, semaglutide, tirzepatide) for weight management in the prior 3 months\n* currently taking anti-psychotic medications (anti-depressants accepted)\n* diagnosis of type 2 diabetes\n* current or lifetime anorexia nervosa or current bulimia nervosa\n* head injury resulting in loss of consciousness \\>30min\n* neurological disorder (e.g., Parkinson's disease) or history of stroke\n* any contraindication to receiving a MRI (e.g., orthodontal braces)\n* psychological\u002Fbehavioral dysfunction (e.g., autism spectrum disorder) or physical impairment that would interfere with study procedures, as determined by study physician\n* if female, desiring to become pregnant, or currently pregnant or breastfeeding","ALL","12 Years","45 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.",[28],"Obesity\u002FTherapy",[30,31,32,33,34,35],"adolescent","adult","brain function","glucagon-like peptide-1 receptor agonists","eating behaviors","appetite sensations","NOT_YET_RECRUITING","2026-06-30",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":22},"2026-06-15",{"date":44,"type":22},"2031-04-30",{"name":46,"class":47},"University of Colorado, Denver","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100585352","phase-4-tirzepatide-in-pws-ho-and-gnso-100585352","NCT06901245","Tirzepatide in PWS, HO and GNSO","The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity and General Non-Syndromic Obesity","Inclusion Criteria:\n\n* Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg\u002Fm2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician, 3) general obesity unrelated to a genetic syndrome or underlying medical condition\n* In a stable care setting at least 6 months prior to enrollment\n* Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan.\n* Ability to take weekly subcutaneous tirzepatide\n* Consistent caregiver if they are not independent\n* Stable diet and exercise regimen for at least 6 months prior to enrollment\n* Able to use contraceptive methods if able to conceive offspring in order to prevent unintentional pregnancy during the study\n\nExclusion Criteria:\n\n* Current or recent (within 3 months of start of study drug initiation) use of weight loss medications\n* Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance\n* Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening\n* Any medications that may affect the study endpoints\n* Significant weight change (\\>3% weight gain or loss) in the last 2 months prior to enrollment\n* Change in dose of chronic endocrine medications (testosterone, estrogen, levothyroxine, or growth hormone medications) \\>10%\u002Fkg\u002Fday for at least 3 months prior to study\n* Current pregnancy or desire to become pregnant within study period, current lactation\n* History of recurrent pancreatitis, CKD, gastroparesis\n* Chronic\u002Facute heart, kidney, or liver disease\n* Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2\n* Uncontrolled diabetes (A1C \\>8.5%)\n* DVT\n* Cancer within the previous 5 years\n* Current participation in an interventional clinical study\n* Previous or planned surgical treatment for obesity\n* Individuals with current substance abuse equivalnt to moderate or severe based on DSM 5 criteria (Hasin DS, 2013)\n* Any suicidal ideation in the past year\n* Unable to perform any of the procedures for the study\n* Have a body weight, height, and\u002For width that that prohibits the ability to obtain accurate measurements according to the DXA manufacturer's specification\n* Any condition that would prevent successful participation in the study.","18 Years","26 Years",{"count":59,"type":22},36,[61],"PHASE4","This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and\u002For hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.",[64,65,28],"Prader-Willi Syndrome","Hypothalamic Obesity",[67,68,69,64,65,70],"Tirzepatide","GLP1 Agonist","Obesity","General Obesity","RECRUITING","2025-09-12",{"date":74,"type":40},"2025-09-16",{"date":76,"type":40},"2025-05-01",{"date":78,"type":22},"2026-12",{"name":80,"class":47},"Grace Kim",3,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":48},"100592013","impact-of-a-perioperative-physical-exercise-and-respiratory-physiotherapy-program-on-the-patient-undergoing-bariatric-surgery-100592013","NCT06987903","Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery","CAPS-OB","Inclusion Criteria:\n\n* Patients undergoing bariatric surgery at the General and Digestive Surgery Department of the Álvaro Cunqueiro Hospital in Vigo.\n* Be over 18 and under 69 years old.\n* Sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patient's refusal to enter the study.\n* Inability to comprehend participation in a study.\n* Urgent interventions.\n* Patients undergoing combined surgery with another surgical service.\n* Patients who cannot read and write or are dependent on a legal representative.\n* Patients on treatment for diabetes with GLP-1 agonists (glucagon-like peptide type 1 agonists) and\u002For SGLT2 inhibitors (sodium-glucose cotransporter type 2 inhibitors) whose dose is not stable in the last 3 months.","69 Years",{"count":91,"type":22},132,[93],"NA","The goal of this clinical trial is to see the impact of a physical exercise programme and respiratory physiotherapy before and after bariatric surgery in obese patients. The main questions it aims to answer are:\n\nCould it help to avoid decompensation of underlying diseases? Could it reduce the risks associated with the intervention and the number of adverse effects during the postoperative period? Could it reduce the number of patients and encourage early discharge? How does exercise affect epigenetics in obese patients undergoing bariatric surgery? Can we correlate epigenectic markers obtained from tissue obtained by invasive procedures such as fat or muscle to those obtained by non-invasive methods such as blood and saliva samples? How does exercise affect the hepatic tissue in obese patients undergoing bariatric surgery? And are the any predictive markers in pre-exercise samples that can correlate with the evolution of liver diseases such asl NALFD or NASH?\n\nResearchers will compare one group of subjects performing the exercise programme and respiratory physiotherapy and anoher group performing the normal activities of routine clinical practice.\n\nParticipants, who are on the surgical waiting list for bariatric surgery, will be assigned to one of the two groups. Participants in group 2 will follow the normal procedure before and after surgery. Participants in group 1 will be asked to do a exercise programme and respiratory physiotherapy before and after surgery.",[96,28,97,98],"Bariatric Surgery and Physical Activity","Bariatric Surgery Complications","Bariatric Patients",[100,69,101,102],"Bariatric surgery","Respiratory physiotherapy","Exercise programme","2025-08-27",{"date":105,"type":40},"2025-09-04",{"date":107,"type":40},"2025-05-07",{"date":109,"type":22},"2026-09-07",{"name":111,"class":47},"Fundacin Biomedica Galicia Sur",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":133,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":48},"100585948","phase-3-semaglutide-treatment-in-type-1-diabetes-100585948","NCT06909006","Semaglutide Treatment in Type 1 Diabetes","Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial","OBES1TY","Inclusion Criteria:\n\n* Type 1 Diabetes for more than 3 years\n* BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis\n\nExclusion Criteria:\n\n* Treated with GLP1-RAs within last 6 months\n* Known intolerance for semaglutide\n* Other forms of diabetes\n* Pregnant or nursing women\n* Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives\n* Liver disease with elevated plasma alanine aminotransferase (ALT) \\> five times and plasma aspartate aminotransferase (AST) \\> five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)\n* Acute or chronic pancreatitis\n* Cancer, unless in complete remission for \\> 5 years or unless basocellular carcinomas\n* History of thyroid adenoma or carcinoma\n* Alcohol\u002Fdrug abuse\n* Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation\n* Receipt of an investigational drug within 30 days prior to visit 0 \u002F Simultaneous participation in any other clinical intervention trial",{"count":121,"type":22},122,[25],"The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.",[125,28,126,127,128,129,130,131,132],"Obesity in Diabetes","Type 1 Diabetes Mellitus (T1DM)","Insulin Sensitivity\u002FResistance","Semaglutide","Lipidomics","Metabolomics","Weight Loss","Glycemic Control for Diabetes Mellitus",[128,69,134,135,136,137,138,139,140,141],"Type 1 Diabetes","Obese Type 1 Diabetics","Insulin sensitivity","Insulin resistance","Weight loss","GLP1-RA","GLP1","Wegovy","2025-08-04",{"date":144,"type":40},"2025-08-08",{"date":146,"type":22},"2025-10",{"date":148,"type":22},"2028-06",{"name":150,"class":47},"Nordsjaellands Hospital",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":81},"100578274","phase-4-metabolic-and-behavioural-effects-of-contrave-as-potential-mechanisms-of-weight-loss-in-adults-with-obesity-100578274","NCT06809166","Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity","Identifying the Short-Term Neurobiological, Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial","Inclusion Criteria:\n\n1. Participants who are able to provide written informed consent prior to the initiation of any protocol-required procedures\n2. Have been referred to the LEAF clinic by their physician or have self-referred to the LEAF clinic for weight loss, and have been deemed appropriate for weight loss treatment offered by the LEAF clinic (i.e., these criteria are at the discretion of the clinical team at the LEAF clinic, outlined below in the exclusion criteria section).\n3. Adults: aged 18-64 years of age (gender and sex will be noted; recruitment is all-gender inclusive).\n4. Have a BMI\\>30.\n5. Have normal or corrected vision as some of the study aspects will involve viewing\u002Fresponding to visual stimuli.\n6. Understand and speak English (as instructions for study criteria will be provided in English).\n7. Able to participate in the study protocol as described, e.g. have a means of getting to the laboratories and no major mobility issues to the extent that protocols cannot be followed (details below).\n8. Access to a secure internet connection (for virtual appointments with members of the LEAF clinic).\n\nExclusion Criteria:\n\n1. Reporting severe depression or reporting significant suicidal ideation, or history of bipolar disorder or psychosis (i.e., major psychiatric condition; this will be ascertained during the screening carried out by research personnel, in keeping with our standard protocols in Dr. Jaworska's laboratory).\\*\\*\\*\n2. Current use of antidepressants, thyroid medication, or any medication that could affect appetite, or seizure threshold (e.g.., bupropion, tamoxifen, thioridazine).\n3. Uncontrolled hypertension.\n4. History of cardiac defects or symptoms suggestive of any cardiac condition (not including coronary artery disease).\n5. Presence of diabetes.\n6. Current or past history of addictions or substance use disorder, including undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.\n7. History of eating disorder (including Binge Eating Disorder, Bulimia Nervosa or Anorexia Nervosa).\n8. History of glaucoma.\n9. Personal or family history of seizure disorders.\n10. Currently taking MAO inhibitors (within 14 days), pressor agents, coumadin, anticonvulsants, or phenylbutazone, or other bupropion-containing products (such as Wellbutrin, Wellbutrin SR, Wellbutrin XL, Aplenzin or Zyban), or CYP2B6 inhibitors (e.g. ticlopidine or clopidogrel).\n11. History of thyroid disease, chronic liver, or renal disease.\n12. Chronic use of opioid, opiate agonist (Methadone) or partial agonists (Buprenorphine).\n13. Currently pregnant or planning to become pregnant during the intervention or currently nursing. Pregnancy urine test will be conducted during the in-person screening session in the laboratory.\\*\\*\\*\n14. No known allergy to any of the ingredients in CONTRAVE® (e.g. lactose).\n15. Hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.\n16. Current use of obesity medications such as liraglutide or semaglutide or orlistat.\n17. Current use of medication indicated in patient living with ADHD (e.g., Vivanse\u002FConcerta) which are known to have metabolic impacts.\n\n    There are several additional exclusionary criteria, established by research personnel in Dr. Jaworska's laboratory (i.e., not part of LEAF intake) that preclude participation in the brain imaging\u002Fmagnetic resonance imaging (MRI) and EEG, these include:\n18. Severe claustrophobia.\n19. Inability to lie still in the scanner for approximately 30min.\n20. Metal in the body that cannot be removed and might pose a safety risk to the participant.\n21. History of concussion (loss of consciousness for \\>5-min).\n22. Major neurological illness, such as, epilepsy, stroke, tumours (as this would interfere with the interpretation of the MRI data).\n23. Obesity to the extent that the participant cannot fit into the scanner. This will be established by ensuring that the individual can fit into the mock scanner at the Brain Imaging Centre (BIC) of The Royal. If a person cannot fit into the mock scanner, it is unlikely that the person can fit into the real scanner.\n24. Testing positive for illicit drugs and cannabis (this will be established using a drug test that will be administered in the Clinical EEG \\& Neuroimaging laboratory at the Institute of Mental Health Research \\[IMHR\\]). Participants who are cannabis users will be invited to participate in the study so long as they can abstain from cannabis use for approximately 2weeks prior to the baseline session and approximately 2weeks before final assessment. Ideally, participants would also abstain from cannabis use during treatment, but, this will not be tested\u002Fenforced.\n25. Ability to abstain from nicotine\u002Ftobacco and caffeine for 3h prior to the baseline testing\u002FEEG recordings, as both substances influence EEG activity.\n\n    NOTE: If a participant cannot participate in the MRI aspect of the study (i.e., due to the above exclusion criteria), they will still be able to participate in the research study (apart from the MRI component). All MRI\u002FEEG exclusion criteria will be established during the screening\u002Fclinical interview carried out by trained research staff from Dr. Jaworska's laboratory (details below).\n\n    One final exclusion criterion is as follows:\n26. Unable to tolerate the test dose of CONTRAVE® (details below). Such individuals would not participate in further elements of the research, but, would continue with their treatment through the LEAF clinic (as determined by the LEAF clinic, per their clinical management program).","64 Years",{"count":160,"type":22},40,[61],"Obesity is a common chronic disease linked with increased risk for other illnesses and earlier death. Our team and others have shown that many bodily and psychological changes occur when individuals are on calorie-restricted diets. These changes might undermine dietary adherence and help to explain the relatively poor long-term efficacy of diets. These include increased appetite, increased food 'value' and 'wanting' that leads to overconsumption. Other factors include more sensitive sensory cues (e.g., smelling), higher food liking and craving, and a drop in resting energy expenditure (REE). REE has been shown to predict weight regain.\n\nThe standard care for obesity may include the use of the weight-loss drug CONTRAVE®. The Federal Drug Agency (FDA) and Health Canada have approved this drug for weight management and obesity treatment.\n\nAlthough CONTRAVE® was designed to reduce appetite, food-related impulsivity and cravings, its mechanisms of action are unclear. In other words, the effects of CONTRAVE® on REE, executive function, and brain changes remain unknown in humans. A better understanding of how this drug works on the brain and body could lead to improvements in obesity management in the future.\n\nAs such, the goal of this research is to study the effects of 4 weeks of CONTRAVE® (+ diet program) vs. control (placebo pill + diet program) on mood, body composition changes, biological\u002Fmetabolic measures, and brain measures.\n\nAdults aged 18-64 with obesity will be randomized to one of two groups: diet + CONTRAVE® (CONTRAVE®, 20 participants) or diet + Placebo (Placebo, 20 participants). Both groups will be assigned the same study procedures for the entire study duration. The only difference is that Group 1 will receive CONTRAVE® while Group 2 will receive a placebo (non-medical) pill.\n\nThe study design and intervention is as follows:\n\nParticipants who meet all the telephone screening criteria will be invited to the Clinical EEG \\& Neuroimaging Laboratory at The Royal's IMHR for an in-person screening and test-dose session. Participants who are cleared by the study physician, Dr. Pierre Blier, during the in-person screening will be enrolled in the 4-weeks trial.\n\nAfter the in-person screening visit, participants will attend two baseline testing visits (before starting the medication + diet program). The first will occur at the Behavioural and Metabolic Research Unit at the University of Ottawa. During this in-person visit, measures of body composition, resting energy expenditure, appetite, food craving, impulsivity, eating behaviours, taste and odour sensitivity, energy intake, and food preference will be collected.\n\nThe second baseline visit (within a week of the first one) will occur at The Royal\u002FIMHR. During this visit, participants will be asked to complete questionnaires. They will undergo an EEG recording while resting and performing computer tasks. They will also get a brain imaging scan, during which they are asked to rest and complete a computer task.\n\nBoth testing sessions (University of Ottawa and Royal Ottawa testing sessions) will be repeated after four weeks of treatment. The section below provides further description and timing of these visits.\n\nAs part of the treatment, you will receive an individualized dietary intervention with appropriate energy restriction from a registered dietitian at Dr. Judy Shiau's LEAF weight management clinic (called the 4-week BUDS program). The program involves weekly touch points with a registered dietitian and meal planning\u002Fcoaching. The diet intervention will commence the same week as the start of the placebo\u002FCONTRAVE®.\n\nDuring the 4-week intervention, participants will be asked to complete online questionnaires at various times.",[69,131,164,165,28],"Weight Management","Dietary Intervention",[167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188],"contrave","EEG","MRI","weight loss","appetitive behaviour","executive functioning","mood and weight loss","mood","body composition","symptoms of anxiety","symptoms of depression","energy expenditure","appetite","energy intake","food reward","reward processing","motivation","effort expenditure","delay discounting","brain activation","event related potentials","brain electrical activity","2025-07-21",{"date":191,"type":40},"2025-07-24",{"date":193,"type":40},"2024-07-04",{"date":195,"type":22},"2026-07-31",{"name":197,"class":47},"The Royal's Institute of Mental Health Research",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":48},"100590499","phase-2-the-efficacy-and-safety-of-puerarin-in-obesity-treatment-100590499","NCT06968208","The Efficacy and Safety of Puerarin in Obesity Treatment","Randomized Controlled Trial of Puerarin for Obesity Treatment","Inclusion Criteria:\n\n1. Aged 18-60 years (inclusive), any gender.\n2. Obesity (BMI ≥30.0 kg\u002Fm²).\n3. With or without obesity-related metabolic comorbidities (e.g., type 2 diabetes, hypertension, dyslipidemia, hyperuricemia).\n4. No prior use of weight-control, glucose-lowering, or lipid-modifying medications.\n5. Stable weight (\\\u003C3% fluctuation) and lifestyle for ≥1 month prior to screening.\n6. Fully informed of trial objectives, procedures, risks, and benefits; voluntarily signed informed consent form.\n\nExclusion Criteria:\n\n1. Secondary causes of obesity (e.g., monogenic obesity, Cushing's syndrome, drug-induced obesity).\n2. History of common nutrient allergies (e.g., gluten, milk, eggs, plant-derived proteins).\n3. Use of weight-control medications (e.g., metformin, GLP-1 receptor agonists, orlistat), corticosteroids (oral\u002FIV\u002FIM\u002Fnon-oral systemic\u002Fintra-articular), or metabolic-interfering drugs\u002Fsupplements within 3 months prior to screening or during the trial.\n4. Use of traditional Chinese medicines or herbal products for weight management within 3 months prior to screening or during the trial.\n5. History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.\n6. Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.\n7. Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).\n8. Severe infections, severe anemia (Hb \\\u003C8 g\u002FdL), or neutropenia (ANC \\\u003C1.5×10⁹\u002FL).\n9. Gastrointestinal surgery within 1 year (excluding appendectomy\u002Fhernia repair) or major non-GI surgery within 6 months.\n10. Active substance\u002Falcohol abuse.\n11. Known hypersensitivity to trial drug components or history of severe drug allergies.\n12. Severe cardiac disorders (e.g., congenital\u002Frheumatic heart disease, cardiomyopathy \\[NYHA ≥III\\], coronary stenting).\n13. Hyperthyroidism or hypothyroidism.\n14. History of malignancies (treated\u002Funtreated), regardless of recurrence status.\n15. Hepatic\u002Frenal dysfunction: ALT\u002FAST ≥2.5×ULN, serum creatinine \\>ULN, or eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (MDRD formula).\n16. Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea\u002Fconstipation).\n17. Participation in other clinical trials within 3 months prior to screening.\n18. Any condition deemed unsuitable by investigators.","60 Years",{"count":207,"type":22},80,[209],"PHASE2","This randomized controlled trial aims to evaluate the therapeutic efficacy of puerarin intervention in weight management and metabolic regulation among obese populations. The study will systematically address two primary endpoints: 1) The capacity of puerarin to induce clinically significant body weight reduction in individuals with BMI ≥30 kg\u002Fm²; 2) Its modulatory effects on postprandial lipid metabolism as measured by serum lipids and quantitative fecal lipid excretion analysis. Secondary outcomes focus on puerarin's pleiotropic effects, including continuous glucose monitoring-derived glycemic parameters and indirect calorimetry-assessed resting metabolic rate. Secondary exploratory objectives include investigating puerarin's potential mechanisms of action through continuous glucose monitoring and indirect calorimetry measurements to assess glycemic variability and resting energy expenditure, respectively. Participants will be randomized into two parallel groups: the intervention group receiving daily oral puerarin injection (75 mg\u002Fday, dissolved in 100 mL of 0.9% sodium chloride solution) and the control group receiving matched blank 100 mL of 0.9% sodium chloride solution, both administered double-blind for 6 consecutive months. Primary efficacy endpoints (body weight, waist circumference, lipid profile) and safety monitoring (adverse events, hematological\u002F biochemical parameters) will be assessed at baseline, 1, 3, and 6 months post-intervention.",[212,28],"Metabolic Diseases",[214,215,216],"Puerarin","Intestinal Lipid Absorption","Dorsal Motor Nucleus of Vagus (DMV)","2025-05-18",{"date":219,"type":40},"2025-05-21",{"date":221,"type":22},"2025-08-01",{"date":223,"type":22},"2029-12-31",{"name":225,"class":47},"Ruijin Hospital",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":233,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":48},"100583384","remote-approaches-for-optimizing-weight-loss-elevate-weight-loss-trial-100583384","NCT06875622","Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)","Comparison of Behaviorally-Based Remote Approaches to Optimize Weight Loss and Identification of Factors Which Characterize Treatment Response","Inclusion Criteria:\n\n* Body Mass Index between 25-45 kg\u002Fm2\n* Daily, home Internet access\n\nExclusion Criteria:\n\n* Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months\n* Current or recent enrollment (\\\u003C2 years) in a weight loss program\n* Presence of any medical condition for which exercise, weight loss, or dietary restriction is contraindicated\n* Recent weight loss (≥10 pounds within the past 6 months)\n* Currently taking weight loss medications or history of bariatric surgery\n* Inability to walk 2 blocks without stopping\n* Non-English speaking\n* A member of one's household is participating in the study\n* History of anorexia or bulimia nervosa",true,{"count":235,"type":22},490,[93],"The purpose of this trial is to compare two delivery formats for weight loss (automated online program vs. group-based videoconference program) and to examine the added effect of individual coaching (vs. no coaching) for individuals with overweight or obesity. All participants enrolled in this study will receive a 12-month behavioral weight loss program (varying in delivery format and individual support), and will be provided with weight loss, calorie intake, and exercise goals. Assessments will occur at baseline, 6 (mid-treatment), 12 (post-treatment), and 18 months (following 6 months of no intervention). We will also seek to determine which combination of intervention approaches works best for whom and develop algorithms which can be used to refer patients into remote programs in clinical settings or future trials.",[239],"Obesity\u002Ftherapy",[241,242,243],"behavioral weight loss","remote interventions","diet and exercise","2025-03-14",{"date":246,"type":40},"2025-03-18",{"date":248,"type":40},"2025-03-03",{"date":250,"type":22},"2028-10-31",{"name":252,"class":47},"The Miriam Hospital"]