Oxytocin for Weight Loss in Adolescents
Recruiting · NCT04551482 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Current substance abuse
- Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or 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/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
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States