[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04551482":3,"trial-entities:NCT04551482":106,"trial-summary:NCT04551482":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":79,"locations":82,"central_contacts":96,"overall_officials":100,"references":104,"see_also_links":105},"NCT04551482","2020P002511","Oxytocin for Weight Loss in Adolescents","Oxytocin as a Neuroendocrine Therapy for Obesity in Youth","RECRUITING","2027-02-28","2026-06","2026-06-26","2021-07-28","Massachusetts General Hospital","OTHER",null,"This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.","In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity.\n\nThe current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 10-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.",[19,20],"Obesity, Adolescent","Oxytocin",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},55,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Oxytocin nasal spray","24 IU nasal spray, 4 times per day for 12 weeks",[20],[36],"Syntocin",{"type":31,"name":38,"description":33,"armGroupLabels":39},"Placebo",[38],[41],{"measure":42,"description":43,"timeFrame":44},"Body mass index (BMI)","Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight\u002Fheight2","12 weeks",[46,49],{"measure":47,"description":48,"timeFrame":44},"Lean mass and Fat mass","Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)",{"measure":50,"description":51,"timeFrame":44},"Fasting Resting Energy Expenditure (kCal)","Assessed by Indirect calorimetry","ALL","10 Years","18 Years",false,{"inclusion":57,"exclusion":61,"raw_text":78},[58,59,60],"Males and Females, 10-18 years","Obesity (BMI ≥95th percentile for age and gender)","Willingness to maintain current diet and lifestyle for the duration of study participation",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"Current substance abuse","Use of prescription or over-the-counter drugs or dietary\u002Fherbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and\u002For if they plan to increase the dose during the 18 weeks of study participation.","Greater than 5kg weight loss over 3 months;","Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)","Cardiovascular disease","Prolonged QT interval","Chronic inflammatory bowel disease and other inflammatory conditions","Epilepsy","TSH \\> 2.5 times upper limit of normal","Alanine transaminase (ALT) or aspartate transaminase (AST) \\>2.5 times upper limit of normal","Creatinine \\>1.5 mg\u002Fdl","Hyponatremia","Pregnancy\u002Fbreastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active","Weight \\>450 lbs due to limits for MRI and DXA scanners","Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \\>8%","Active eating disorder","Inclusion Criteria:\n\n* Males and Females, 10-18 years\n* Obesity (BMI ≥95th percentile for age and gender)\n* Willingness to maintain current diet and lifestyle for the duration of study participation\n\nExclusion Criteria:\n\n* Current substance abuse\n* Use of prescription or over-the-counter drugs or dietary\u002Fherbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and\u002For if they plan to increase the dose during the 18 weeks of study participation.\n* Greater than 5kg weight loss over 3 months;\n* Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)\n* Cardiovascular disease\n* Prolonged QT interval\n* Chronic inflammatory bowel disease and other inflammatory conditions\n* Epilepsy\n* TSH \\> 2.5 times upper limit of normal\n* Alanine transaminase (ALT) or aspartate transaminase (AST) \\>2.5 times upper limit of normal\n* Creatinine \\>1.5 mg\u002Fdl\n* Hyponatremia\n* Pregnancy\u002Fbreastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active\n* MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips\n* Weight \\>450 lbs due to limits for MRI and DXA scanners\n* Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \\>8%\n* Active eating disorder",[80,81],"CHILD","ADULT",[83],{"facility":13,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":93},"Boston","Massachusetts","02114","United States",[89],{"name":90,"role":91,"email":92},"Elizabeth A Lawson, MD","CONTACT","ealawson@partners.org",{"lat":94,"lon":95},42.35843,-71.05977,[97],{"name":98,"role":91,"phone":99,"email":92},"Elizabeth A Lawson, MD, MMSc","617-726-3870",[101],{"name":102,"affiliation":13,"role":103},"Elizabeth Lawson, MD, MMSc","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Obesity",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":15},true,{"design":113,"status":114,"heading":6,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either oxytocin nasal spray or a placebo (an inactive spray), and neither you nor the researchers will know which you are receiving. About 55 participants are planned for this study.","completed","This study is looking into whether oxytocin nasal spray can help adolescents (young people aged 10-18) with obesity lose weight. Researchers want to see if oxytocin, a natural hormone, can help by possibly reducing how much food is eaten and increasing how many calories are burned. You could be eligible if you are between 10 and 18 years old, have obesity (a body mass index, or BMI, at or above the 95th percentile for your age and gender), and are willing to keep your current diet and lifestyle during the study. The main goal is to see if there's a change in your BMI after 12 weeks. The current status of this study is unclear.","There will be a safety follow-up visit 6 weeks after your last dose of the study drug.",115,"You would use a nasal spray four times a day for 12 weeks. This study involves screening, main study visits at baseline, week 8, and week 12, safety check-in visits at weeks 1 and 4, and phone calls at weeks 2, 6, and 10.","Not stated in the trial record.",[32]]