The Effects of Oxytocin in Obese Adults

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study visits include screening to determine eligibility, a 2-part baseline visit, and visits every 2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine assessments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• 18-45 years old;

• BMI 30-50 kg/m2

Exclusion Criteria:

• Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);

• history of medication changes within 4 weeks of enrollment;

• active substance use;

• history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;

• hematocrit >2% below normal;

• fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;

• ALT or AST >2.5 times upper limit of normal;

• Cr >1.5 mg/dL; hyponatremia;

• pregnancy or breastfeeding;

• unwilling to use medically acceptable form of contraception (females only)

• follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)

• current smoking or tobacco use