The Effects of Oxytocin in Obese Adults

NCT ID: NCT03043053

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2022-07-07

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oxytocin

oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)

Group Type: EXPERIMENTAL

oxytocin nasal spray

Intervention Type: DRUG

oxytocin intranasal spray

placebo

placebo nasal spray (4 times per day for 8 weeks)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo nasal spray

Interventions

oxytocin nasal spray

oxytocin intranasal spray

Intervention Type: DRUG

Placebo

Placebo nasal spray

Intervention Type: DRUG

Other Intervention Names

Syntocinon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Austen Lawson

Associate Professor of Medicine, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A Lawson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Plessow F, Kerem L, Wronski ML, Asanza E, O'Donoghue ML, Stanford FC, Eddy KT, Holmes TM, Misra M, Thomas JJ, Galbiati F, Muhammed M, Sella AC, Hauser K, Smith SE, Holman K, Gydus J, Aulinas A, Vangel M, Healy B, Kheterpal A, Torriani M, Holsen LM, Bredella MA, Lawson EA. Intranasal Oxytocin for Obesity. NEJM Evid. 2024 May;3(5):EVIDoa2300349. doi: 10.1056/EVIDoa2300349. Epub 2024 Apr 23.

Reference Type: DERIVED

PMID: 38815173 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P002810

Identifier Type: -

Identifier Source: org_study_id