[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"weight-change\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:weight-change":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,52,83,109,138,171,203,227,255],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100635720","empowering-faith-based-communities-to-provide-personalized-diabetes-self-management-education-and-support-dsmes-in-the-magic-city-100635720",false,"NCT07556354","Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City","Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study","MCPILOTDSMES","Inclusion Criteria:\n\n* Have a prior diabetes (Type 1, Type 2, or Gestational) or prediabetes diagnosis\n* Are aged 18 or older\n* Live in Jefferson County, Alabama\n* Have never participated in a DSMES program\n\nExclusion Criteria:\n\n* Not a resident of Jefferson County, Alabama\n* Completed a DSMES program",true,"ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.",[28,29,30,31,32,33],"Blood Cholesterol","Blood Pressure Monitoring","Weight Change","BMI","Diabetes Education","Diabetes (DM)",[35,36,37,38],"dsmes","diabetes education","faith based intervention","remote patient monitoring","RECRUITING","2026-06-29",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":22},"2026-07",{"date":47,"type":22},"2026-10",{"name":49,"class":50},"University of Alabama at Birmingham","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100629395","fluid-vs-weight-24-hour-balance-100629395","NCT07474116","Fluid vs Weight 24 Hour Balance","More Than a Number: Why Daily Fluid Balance Alone Should Not Guide Clinical Decision-Making in the ICU: A Prospective Observational Study","Bilance24","Inclusion criteria:\n\n\\- adult (age ≥ 18 years) patients admitted to intensive care unit.\n\nExclusion criteria:\n\n* age \\\u003C18 years\n* pregnancy\n* inability to obtain standardized daily body weight using the ICU bed scale\n* incomplete 24-hour fluid balance data preventing calculation of cumulative balance\n* absence of an indwelling urinary catheter, extracorporeal life support (ECMO) or other extracorporeal circulation\n* open abdomen\n* open chest\n* lavage or irrigation procedures during the assessment interval\n* surgery during the assessment\n* massive bleeding\n* diarrhoea during the assessment period\n* massive transfusion protocol during the 24-hour interval and ICU stay shorter than 24 hours.",{"count":61,"type":22},55,"OBSERVATIONAL","Daily Fluid Balance vs Weight Change",[65,30,66,67],"Weight Bias","Fluid Balance","Fluid Accumulation",[69,70,71,72],"fluid balance","weight change","fluid accumulation","fluid deresuscitation","NOT_YET_RECRUITING","2026-03-11",{"date":76,"type":43},"2026-03-16",{"date":78,"type":22},"2026-05-01",{"date":80,"type":22},"2026-09-01",{"name":82,"class":50},"Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":51},"100626994","hunger-perception-and-weight-related-outcomes-following-use-of-a-leptin-supporting-dietary-supplement-100626994","NCT07442864","Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement","Evaluation of Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement Over 12 Weeks","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Willing to pay for study supplies and able to take the dietary supplement daily for 12 weeks\n* Willing to complete electronic questionnaires and self-reported measurements\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding individuals\n* Known allergy or sensitivity to any supplement ingredients\n* Use of medications or supplements that could interfere with appetite or weight without medical clearance\n* Any medical condition that would make participation unsafe, as determined by the participant",{"count":91,"type":22},100,[25],"This study evaluates changes in hunger perception and body composition-related measures following daily use of a commercially available dietary supplement formulated to support leptin-related metabolic signaling. Adult participants will self-administer the supplement for 12 weeks and complete periodic self-reported assessments related to appetite, hunger, and weight-related outcomes. Participants serve as their own control, with comparisons made between baseline and follow-up measurements. The study is designed to generate preliminary, real-world evidence regarding supplement use in a general wellness context.",[95,30],"Hunger",[95,97,98],"Leptin","Weight Management","2026-02-24",{"date":101,"type":43},"2026-03-02",{"date":103,"type":43},"2025-09-10",{"date":105,"type":22},"2026-09-10",{"name":107,"class":108},"Efforia, Inc","INDUSTRY",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":51},"100615618","phase-3-impact-of-semaglutide-withdrawal-on-cardiometabolic-profile-and-physiology-of-energy-balance-recovery-effects-after-semaglutide-termination-100615618","NCT07294950","Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination","Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: a Randomized Controlled Trial Comparing Gradual Dose Reduction With Immediate Treatment Cessation.","REST","Inclusion Criteria:\n\n* Men and women with previously diagnosed BMI ≥ 30 kg\u002Fm2 or BMI ≥ 27 kg\u002Fm2 and adiposity-related complications (such as osteoarthritis, nonalcoholic liver disease, sleep apnea, and hypertension) without preexisting cardiovascular disease or type 2 diabetes.\n* Age 18 - 75 years inclusive\n* Ongoing weight-loss treatment consisting of weekly subcutaneous semaglutide at minimum dose of 1 mg\u002Fweekly with documented weight reduction of at least 10% of pre-treatment body weight\n* Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Previously diagnosed cardiovascular disease defined as previous myocardial infarction, previous stroke, or symptomatic peripheral arterial disease.\n* Currently pregnant or lactating\n* Previously diagnosed type 2 diabetes\n* Use of any other pharmacological treatment for weight-loss\n* Previous surgical treatment for weight loss such as gastric bypass or gastric band\n* Any history of eating disorder\n* Renal dysfunction as evidenced by estimated glomerular filtration rate \\\u003C 25 ml\u002Fmin by CKD-EPI Creatinine Equation\n* New York Heart Association class II-IV heart failure\n* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \\>2.5X the upper limit of normal\n* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)\n* Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2\n* Any other factor likely to limit adherence to the study, in the opinion of the investigators","75 Years",{"count":119,"type":22},98,[121],"PHASE3","Semaglutide is a medication from the class of drugs called glucagon-like peptide-1 agonists that promote weight loss. There is little clinical data on the best strategy to achieve weight maintenance following weight reduction induced by semaglutide. For people who need to discontinue treatment, it is unknown whether the weight regain, its accompanied health benefits could be ameliorated with a gradual reduction in semaglutide. The investigators will study if a gradual reduction of semaglutide is associated with different heart risk profile and hormones involved in energy regulation as compared to immediate treatment cessation.",[124,30,29,125],"Obesity (Disorder)","Appetite Regulation",[127,128],"Randomized controlled trial","Interventional","2026-02-09",{"date":131,"type":43},"2026-02-11",{"date":133,"type":43},"2026-02-01",{"date":135,"type":22},"2029-05",{"name":137,"class":50},"Mount Sinai Hospital, Canada",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":51},"100576420","optimizing-an-extended-care-intervention-to-promote-weight-loss-maintenance-100576420","NCT06785064","Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance","OPT-X: OPTimizing an EXtended Care Intervention to Promote Weight Loss Maintenance","OPT-X","Inclusion Criteria:\n\n* Age \\>18 years\n* Body mass index (BMI) \\>30 kg\u002Fm2\n* Has regular access to internet (to access Zoom videoconferencing platform)\n* If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment\n\nExclusion Criteria:\n\n* Current or recent (past 6 months) use of prescription weight loss medications\n* Weight loss \\>10 pounds in past 6 months (other than postpartum)\n* Pregnancy or anticipating pregnancy\n* Another household member already participating in the study\n* Participation in another randomized research project\n* Uncontrolled hypertension (blood pressure \\>160\u002F100 mm Hg at screening)\n* Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last 6 months; unstable angina within the past 6 months; NYHA Class III or IV congestive heart failure; type 1 diabetes; and chronic lung diseases that limit physical activity\n* Unable to identify potential buddy (i.e., adult friend or family member) for extended care intervention phase\n* Residing \\>50 miles from the university (to attend assessment visits)\n* Planning to relocate out of the area in the next 18 months\n* Does not have internet access\n* Unwilling or unable to do any of the following: give informed consent; read\u002Funderstand English; accept random assignment",{"count":147,"type":22},544,[25],"The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people.\n\n* The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance.\n* The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people.\n\nParticipants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off.\n\nThe four components participants could be assigned to in Phase 2 are:\n\n1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly\n2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home\n3. Buddy Training and Support: Having a friend or \"buddy\" get trained to support the participant\n4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way\n\nParticipants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.",[151,30,152,153],"Obesity Prevention","Weight Loss","Weight Loss Maintenance",[155,156,70,157,158,159,160,161,162],"weight loss maintenance","weight loss","health behavior","reduced food variety","ACT workshop","buddy support","home-based resistance training","weight training","2026-01-06",{"date":165,"type":43},"2026-01-07",{"date":167,"type":43},"2025-12-02",{"date":169,"type":22},"2029-02-28",{"name":49,"class":50},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":189,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":201,"locationsCount":4},"100600579","interactive-vs-standard-video-education-for-improving-outcomes-in-hemodialysis-patients-100600579","NCT07099326","Interactive vs. Standard Video Education for Improving Outcomes in Hemodialysis Patients","Examining the Effects of Interactive Versus Conventional Video-Based Education on Activation, Treatment Adherence, and Weight Changes in Dialysis Patients: A Randomized Clinical Trial Protocol","Inclusion Criteria:\n\n1. Willingness to participate in the study;\n2. Literate (ability to read and write);\n3. Alertness and orientation to time, place, and person sufficient to respond to questions;\n4. No history of hearing or visual impairments;\n5. No cognitive disorders;\n6. Possession of a personal mobile phone or any other device capable of running interactive videos, and the ability to use it;\n7. No use of psychoactive medications;\n8. Confirmed diagnosis of chronic kidney disease by a nephrology specialist and having a medical record in the dialysis unit;\n9. Age between 18 and 65 years.\n\nExclusion Criteria:\n\n1. Withdrawal from the study at any stage;\n2. Failure to receive and watch the provided videos;\n3. Patient death;\n4. Transfer to a healthcare center outside the coverage of Shahid Beheshti University of Medical Sciences.","65 Years",{"count":180,"type":22},165,[25],"The goal of this clinical trial is to find out if educational videos-especially interactive ones-can help people on dialysis better manage their treatment.\n\nResearchers want to answer the following main questions:\n\nCan interactive or conventional video-based education help patients better understand and follow their treatment plan? Does this type of education improve patients' ability to control their weight changes between dialysis sessions? Does this type of education improve patients' activation? Is interactive video education more effective than regular (non-interactive) video education?\n\nWhat Will Happen in the Study:\n\nAdults on hemodialysis will take part in the study.\n\nThey will be randomly assigned to one of three groups:\n\nGroup A: Will receive 10 interactive educational video sessions (30 minutes each).\n\nGroup B: Will receive the same videos but in a non-interactive format. Group C (Control Group): Will receive routine education normally given at the dialysis center.\n\nVideos will be watched on a web platform. Interactive videos include pop-up questions and scenario-based feedback.\n\nAll participants will be followed up immediately, 1 month, and 3 months after the program ends.\n\nWhat Participants Will Do:\n\nWatch educational videos over several days (totaling 5 hours).\n\nAnswer questions and engage in follow-up group discussions.\n\nComplete surveys about their knowledge, treatment adherence, and health behaviors.\n\nGet weighed before and after dialysis sessions to monitor fluid retention.\n\nThis study aims to improve how dialysis patients manage their condition and to help healthcare providers design better educational tools.",[184,185,186,187,30,188],"Hemodialysis","Nurse","Educational Videos","Patient Activation","Treatment Adherence",[190,191,187,192,193,194],"Interactive Video-Based Education","Conventional Video-Based Education","Patient Treatment Adherence","Patients' Weight Changes","Dialysis","2025-07-31",{"date":197,"type":43},"2025-08-05",{"date":197,"type":22},{"date":200,"type":22},"2025-10-05",{"name":202,"class":50},"Shahid Beheshti University of Medical Sciences",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":51},"100594639","evolving-azimuth-in-musa-context-100594639","NCT07022067","EVOLVING AZIMUTH IN MUSA CONTEXT","AZIMUSA","Inclusion Criteria:\n\n* Have been diagnosed with chronic CS according to the ESC guidelines;\n* Over 18 years of age;\n* Patients admitted to hospital or with access to first aid within the last year;\n* Smartphome that meets the digital requirements (ie Android or iOS able to download and use the application);\n* Wi-Fi or 3G coverage at home;\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* Severe psychiatric disorder\n* Inability to use portable technologies\n* Patients unable to use the equipment provided\n* Patients who deny consent to study participation",{"count":211,"type":22},184,[25],"Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure",[215,216,30,217],"Heart Failure","Blood Pressure","Telemonitoring","2025-06-11",{"date":220,"type":43},"2025-06-15",{"date":222,"type":43},"2024-10-02",{"date":224,"type":22},"2025-08-31",{"name":226,"class":50},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":17,"sex":18,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":244,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":51},"100593835","integrated-childhood-activity-and-nutrition-ican-study-100593835","NCT07011602","INTEGRATED CHILDHOOD ACTIVITY AND NUTRITION (ICAN) STUDY","ICAN","Inclusion Criteria:\n\n* Parental\u002Fguardian consent\n* Child assent\n* Child participant is between the chronological age of 6-11 years.\n* Child participant is considered economically or educationally disadvantaged (e.g., eligible for Supplemental Nutritional Assistance Program \\[SNAP\\] and\u002For qualifies for free-and-reduced lunch.\n* Child participant must have 20\u002F20 or corrected 20\u002F20 vision.\n* Child participant absent of cognitive or neurological disorder (e.g., autism spectrum disorder)\n\nExclusion Criteria:\n\n* Parental\u002Fguardian does not provide consent\n* Child non-assent\n* Child participant chronological age when enrolling into the iCANS program falls below 6 or above 11 years of age\n* Child participant is not eligible for SNAP or does not qualify for free-and-reduced lunch.\n* Child participant does not have 20\u002F20 or corrected 20\u002F20 vision.\n* Presence of cognitive or neurological disorder (e.g., autism spectrum disorder)","6 Years","11 Years",{"count":91,"type":22},[25],"This study is a multi-functional integrated research and education project to prevent losses in academic achievement, cognitive function, and behavioral health among at-risk youth. The study tests the effects of a 8-week nutrition and physical activity-based program (Integrated Childhood Activity and Nutrition \\[ICAN\\]) to prevent summer learning loss. Outcomes include standardized academic achievement as well as executive function among 6-10-year-olds affected by poverty. The nutrition component of the intervention involves daily consumption of a snack containing the carotenoid lutein, typically found in high quantities in green leafy vegetables. The physical activity components will involve group games or activities.",[240,30,241,242,243],"Achievement","Cognition","Fitness","Nutrition Status",[245],"brain, exercise, carotenoids, body composition","2025-06-05",{"date":248,"type":43},"2025-06-09",{"date":250,"type":43},"2025-06-04",{"date":252,"type":22},"2027-07-31",{"name":254,"class":50},"University of Illinois at Urbana-Champaign",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":263,"minAge":19,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":269,"conditions":270,"keywords":275,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":290},"100562396","phase-4-change-in-body-weight-and-bmi-in-pwh-with-dor3tctdf-compared-with-insti-100562396","NCT06602622","Change in Body Weight and BMI in PWH with DOR\u002F3TC\u002FTDF Compared with INSTI","Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR\u002F3TC\u002FTDF At 48 Weeks","TLATOANI","Inclusion Criteria:\n\n1. Virologically suppressed for at least 48 weeks prior to study entry\n2. Coming from a regimen containing Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF), Dolutegravir\u002FLamivudine\u002FAbacavir (DTG\u002F3TC\u002FABC), or, Dolutegravir\u002FTenofovir Disoproxil Fumarate\u002FEmtricitabine (DTG+TDF\u002FFTC) with no known failures to integrase inhibitors for al least 48 weeks.\n3. BMI ≥25 kg\u002Fm2 at screening and\n4. Unintentional weight gain of \\>10% from baseline (prior to INSTI initiation) within 1-3 years of starting INSTI ART, with no other apparent medical reason to explain the weight gain (concomitant medication use, Cushing's disease, recent prolonged hospitalization, etc.), in the opinion of the site investigator.\n5. Body fat percentage \\>20%\n6. No indication or plans to add or change medications associated with significant weight change during the study period.\n7. Participants currently receiving antipsychotics, antidepressants, anticonvulsants\u002Fmood stabilizers, and thyroid replacement hormones without dose modifications for at least 12 weeks prior to randomization\n8. Participants currently receiving antidiabetics known to cause weight loss and without dose modifications for at least 24 weeks prior to randomization (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin).\n9. Agree to adhere to assigned ART during the study period\n10. HIV-1 RNA screening \\<50 copies\u002FmL performed within 45 days prior to study entry.\n11. GFR by CDK-EPI ≥60 mL\u002Fmin\n12. Alanine aminotransferase (ALT) and asparatate aminotransferase (AST) \\< 90 IU\u002FL\n13. Thyroid profile (TSH, free T3 and free T4) prior to entering the study\n14. Serum and urinary electrolytes, cystatin C, prior to entering the study\n\nExclusion Criteria:\n\n1. Loss of social security\n2. Allergy to any of the components of ART, previously unknown.\n3. Withdrawal of informed consent\n4. Acquiring HBV and\u002For HCV infection during follow-up.\n5. HIV-1 RNA \\>200 copies\u002FmL in 2 consecutive determinations after having achieved virological suppression.\n6. Early initiation or discontinuation of any of the following drugs after entering the study: antipsychotics (clozapine, olanzapine, risperidone); antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors) monoamine oxidase inhibitors, associated with weight gain; anticonvulsants\u002Fmood stabilizers (lithium, valproic acid) or associated with weight loss (topiramate); thyroid replacement hormones;\n7. Change in dose or discontinuation of antidiabetic drugs that cause weight loss (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin), after entering the study.\n8. Planning to undergo or having undergone bariatric surgery.\n9. Initiating significant dietary changes, advised by a nutritionist according to what was reported by the participant\n10. Initiating or increasing physical exercise or enrolling in a structured weight loss regimen: \\<250 minutes\u002Fweek of moderate to intense activity","MALE","80 Years",{"count":266,"type":22},108,[268],"PHASE4","Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC\u002FTAF\u002FFTC, DTG\u002FABC\u002F3Tc or DTG+TDF\u002FFTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg\u002Fm2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine\u002Flamivudine\u002Fdisoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.",[271,272,273,274,30,152],"HIV","HIV Associate Weight Loss","HIV-1 Infection","Integrase Inhibitors, HIV; HIV PROTEASE INHIB",[271,276,277,278,279],"Integrase inhibitors","doravirine","Body Mass Index","Body Weight Changes","2024-09-17",{"date":282,"type":43},"2024-09-19",{"date":284,"type":43},"2024-08-14",{"date":286,"type":22},"2025-11-14",{"name":288,"class":289},"Instituto Mexicano del Seguro Social","OTHER_GOV",2]