Oxytocin for Weight Loss in Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oxytocin as a Neuroendocrine Therapy for Obesity in Youth

Conditions
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Obesity, Adolescent, Oxytocin

Intervention / Treatment
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* Drug: Oxytocin nasal spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Oxytocin nasal spray (24 IU nasal spray, 4 times per day for 12 weeks) | Drug: Oxytocin nasal spray<br>* 24 IU nasal spray, 4 times per day for 12 weeks<br>* Other names: Syntocin;|
| Placebo Comparator: Placebo<br>Placebo nasal spray (24 IU nasal spray, 4 times per day for 12 weeks) | Drug: Placebo<br>* 24 IU nasal spray, 4 times per day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Mean difference in weight between Oxytocin and Placebo group after 12 weeks of treatment | 12 weeks | 
| Height | Measure height on a stadiometer to the nearest 0.1 cm | Baseline | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean mass and Fat mass | Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg) | 12 weeks | 
| Fasting Resting Energy Expenditure (kCal) | Assessed by Indirect calorimetry | 12 weeks |