Obesity, Adolescent Clinical Trial
Official title:
Oxytocin as a Neuroendocrine Therapy for Obesity in Youth
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (3 sprays 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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | March 31, 2027 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - Males and Females, 12-18 years - Obesity (BMI =95th percentile for age and gender) - Willingness to maintain current diet and lifestyle for the duration of study participation Exclusion Criteria: - Active substance abuse - Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months. - Greater than 5kg weight loss over 3 months; - Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet) - Cardiovascular disease - Prolonged QT interval - Chronic gastrointestinal disorders and other inflammatory conditions - Epilepsy - Untreated thyroid disease - Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal - Creatinine >1.5 mg/dl - Hyponatremia - Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active - MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight | Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment | 12 weeks | |
Primary | Height | Measure height on a stadiometer to the nearest 0.1 cm | Baseline | |
Primary | Body mass index (BMI) | Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2 | 12 weeks | |
Secondary | Lean mass and Fat mass | Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg) | 12 weeks | |
Secondary | Fasting Resting Energy Expenditure (kCal) | Assessed by Indirect calorimetry | 12 weeks |
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