Oxytocin for Weight Loss in Adolescents

Obesity, Adolescent Clinical Trial

Official title:

Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551482
• Other study ID #: 2020P002511
• Status: Recruiting
• Phase: Phase 2
• Start date: July 28, 2021
• Est. completion date: September 2027

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Elizabeth A Lawson, MD, MMSc
• Phone: 617-726-3870
• Email: ealawson[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 12-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

Description:

In recent years there has been a dramatic increase in obesity and its complications in both children and adults. Earlier treatment substantially reduces the likelihood of developing complications later in life while concurrently improving quality of life and decreasing mortality. Therefore, it is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents. Oxytocin (OXT), a hypothalamic peptide hormone that regulates energy balance, is a novel neuroendocrine weight-loss therapeutic in adults with obesity because it simultaneously reduces energy intake and increases energy expenditure and is well-tolerated. Data are currently lacking regarding effects of OXT administration in adolescents with obesity. The current study is a 12-week randomized controlled trial (RCT) of OXT vs. placebo in 12-18-year old adolescents with obesity. We hypothesize that OXT administration will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, both partially mediated by reduced hypothalamic inflammation (such inflammation drives weight gain by increasing food intake and reducing energy expenditure). Further, OXT will improve metabolic risk markers, such as visceral and intrahepatic fat, systemic inflammation, and serum lipids.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Males and Females, 12-18 years
• Obesity (BMI =95th percentile for age and gender)
• Willingness to maintain current diet and lifestyle for the duration of study participation

Exclusion Criteria:

• Active substance abuse
• Use of prescription or over-the-counter drugs or dietary/herbal supplements for the purpose of weight loss. Medications/supplements that may affect weight will be allowed if participants are on a stable dose with stable weight for at least 3 months.
• Greater than 5kg weight loss over 3 months;
• Follows a nonstandard diet (e.g., gluten-free, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
• Cardiovascular disease
• Prolonged QT interval
• Chronic gastrointestinal disorders and other inflammatory conditions
• Epilepsy
• Untreated thyroid disease
• Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times upper limit of normal
• Creatinine >1.5 mg/dl
• Hyponatremia
• Pregnancy/breastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active
• MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips
• Weight >450 lbs due to limits for MRI and DXA scanners
• Type 1 DM or type 2 Diabetes Mellitus if HbA1c >8%
• Active eating disorder

Related Conditions & MeSH terms

• Obesity
• Obesity, Adolescent
• Oxytocin
• Pediatric Obesity

Intervention

Drug:
• Oxytocin nasal spray
24 IU nasal spray, 4 times per day for 12 weeks
• Placebo
24 IU nasal spray, 4 times per day for 12 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment	12 weeks
Primary	Height	Measure height on a stadiometer to the nearest 0.1 cm	Baseline
Primary	Body mass index (BMI)	Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2	12 weeks
Secondary	Lean mass and Fat mass	Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)	12 weeks
Secondary	Fasting Resting Energy Expenditure (kCal)	Assessed by Indirect calorimetry	12 weeks