The Effects of Oxytocin in Obese Adults

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Repeat Doses of Intranasal Oxytocin in Obese Adults

Conditions
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Obesity

Intervention / Treatment
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* Drug: oxytocin nasal spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin<br>oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks) | Drug: oxytocin nasal spray<br>* oxytocin intranasal spray<br>* Other names: Syntocinon;|
| Placebo Comparator: placebo<br>placebo nasal spray (4 times per day for 8 weeks) | Drug: Placebo<br>* Placebo nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in weight loss between Oxytocin and placebo 8 weeks after Baseline | The difference between the mean weight loss values between Oxytocin and placebo-treated groups at 8 weeks after Baseline | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting energy expenditure after 8 weeks of Oxytocin versus placebo | Change in resting energy expenditure from Baseline to 8 weeks in the oxytocin versus placebo-treated groups | Baseline to 8 weeks | 
| Change in fat depots after 8 weeks of Oxytocin versus placebo | Change in fat depots from baseline to 8 weeks in the Oxytocin versus placebo-treated groups | Baseline to 8 weeks | 
| Difference in caloric intake after 6 weeks of Oxytocin versus placebo | Difference in caloric intake after 6 weeks of Oxytocin versus placebo treatment | Baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, body mass index, oxytocin, magnetic resonance imaging