Obesity, Adolescent, Oxytocin
Conditions
Brief summary
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray 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.
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 10-18-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.
Interventions
DRUGOxytocin nasal spray
24 IU nasal spray, 4 times per day for 12 weeks
DRUGPlacebo
24 IU nasal spray, 4 times per day for 12 weeks
Sponsors
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Males and Females, 10-18 years * Obesity (BMI ≥95th percentile for age and gender) * Willingness to maintain current diet and lifestyle for the duration of study participation
Exclusion criteria
* Current substance abuse * Use of prescription or over-the-counter drugs or dietary/herbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and/or if they plan to increase the dose during the 18 weeks of study participation. * Greater than 5kg weight loss over 3 months; * Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet) * Cardiovascular disease * Prolonged QT interval * Chronic inflammatory bowel disease and other inflammatory conditions * Epilepsy * TSH \> 2.5 times upper limit of normal * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTElizabeth A Lawson, MD, MMSc
PRINCIPAL_INVESTIGATORElizabeth Lawson, MD, MMSc
Massachusetts General Hospital
Outcome results
None listed