Oxytocin for Weight Loss in Adolescents

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 10, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a nasal spray called oxytocin on weight loss in adolescents aged 12 to 18 who are struggling with obesity. The trial is designed to see if this spray, taken three times a day, can help participants reduce their weight over a 12-week period compared to a placebo, which looks the same but has no active ingredients. Participants will attend several study visits to check their health, monitor their appetite, and evaluate their behaviors related to eating and metabolism.

To be eligible for the study, participants must be between 12 and 18 years old and have a body mass index (BMI) that is higher than 95% of their peers. They also need to be willing to maintain their current diet and lifestyle throughout the study. Some individuals may not qualify, including those with certain medical conditions, active substance abuse, or those who have lost a significant amount of weight recently. Participants can expect regular check-ins, both in person and via phone, to ensure their safety and track their progress. This trial is an opportunity to explore a potential new approach to help young people manage their weight.

Gender

ALL

Eligibility criteria

• 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