The Effects of Oxytocin in Obese Adults

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: oxytocin nasal spray; Drug: Placebo

• Registration Number: NCT03043053
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-07-01
• Primary Completion: 2022-05-20
• Study Completion: 2022-07-07
• Disposition First Submitted: 2023-05-11
• Results First Submitted: 2023-08-22
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Results First Posted: 2024-02-07
• Disposition First Posted: 2024-02-07
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• 18-45 years old;
• BMI greater than or equal to 30 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	oxytocin nasal spray	oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
placebo	Placebo	placebo nasal spray (4 times per day for 8 weeks)

Primary Outcome Measures

Name	Time	Method
Mean Difference in Weight Loss Between Oxytocin and Placebo 8 Weeks After Baseline	Baseline to 8 weeks	The mean difference in weight loss between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline, Week 2, Week 4, Week 6, and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.

Secondary Outcome Measures

Name	Time	Method
Change in Fat Depots After 8 Weeks of Oxytocin Versus Placebo	Baseline to 8 weeks	The mean difference in total fat mass between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.
Change in Resting Energy Expenditure After 8 Weeks of Oxytocin Versus Placebo	Baseline to 8 weeks	The mean difference in resting energy expenditure between oxytocin- and placebo-treated groups from baseline to 8 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 8) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female), obesity class (class I, II, and III), and lean mass to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group. Reported are model estimates rounded to one decimal.
Difference in Caloric Intake After 6 Weeks of Oxytocin Versus Placebo	Baseline to 6 weeks	The mean difference in caloric intake between oxytocin- and placebo-treated groups from baseline to 6 weeks. All participants of the modified intention-to-treat cohort were aggregated into a single linear mixed effects model with the factors Time (Baseline and Week 6) and Group (oxytocin/placebo) and the interaction Time\*Group controlled for sex (male/female) and obesity class (class I, II, and III) to produce a single value (estimated mean difference) and 95% confidence interval for the difference between groups and a single value (estimated mean change) within each group.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States