The Effects of Oxytocin in Obese Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 9/13/2018 |
| Start Date: | July 1, 2017 |
| End Date: | April 1, 2021 |
| Contact: | Elisa Asanza, MSN, MPH |
| Email: | easanza@partners.org |
| Phone: | 617-726-9394 |
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-9394
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