Oxytocin for Weight Loss in Adolescents
Study Details
Study Description
Brief 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, 2, 4, and 6, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oxytocin Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks) |
Drug: Oxytocin nasal spray
24 IU nasal spray, 4 times per day for 12 weeks
Other Names:
|
| Placebo Comparator: Placebo Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks) |
Drug: Placebo
24 IU nasal spray, 4 times per day for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Weight [12 weeks]
Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment
- Height [Baseline]
Measure height on a stadiometer to the nearest 0.1 cm
- Body mass index (BMI) [12 weeks]
Mean difference in BMI between Oxytocin and Placebo group after 12 weeks of treatment. BMI will be calculated as weight/height2
Secondary Outcome Measures
- Lean mass and Fat mass [12 weeks]
Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)
- Fasting Resting Energy Expenditure (kCal) [12 weeks]
Assessed by Indirect calorimetry
Eligibility Criteria
Criteria
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 affecting metabolism, blood glucose, or appetite. Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months
-
Greater than 5kg weight change 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
-
Use of oral contraceptive pills
-
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 and type 2 Diabetes Mellitus if HbA1c >8%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Madhusmita Misra, MD, MPH, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020P002511