The Effects of Oxytocin in Obese Adults
Purpose
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.
Condition
- Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18-45 years old; - BMI greater than or equal to 30 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental oxytocin |
oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) |
|
Placebo Comparator placebo |
placebo nasal spray (4 times per day for 8 weeks) |
|
More Details
- Status
- Completed
- Sponsor
- Massachusetts General Hospital