The Effects of Oxytocin in Obese Adults

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Obesity

Treatments

Drug: Placebo

Drug: oxytocin nasal spray

Study type

Interventional

Funder types

Other

Identifiers

NCT03043053

2016P002810

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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