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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04551482
Other study ID # 2020P002511
Secondary ID 1R01DK124223-01A
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 28, 2021
Est. completion date March 31, 2027

Study information

Verified date May 2024
Source Massachusetts General Hospital
Contact Elizabeth A Lawson, MD, MMSc
Phone 617-726-3870
Email ealawson@partners.org
Is FDA regulated No
Health authority
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 March 31, 2027
Est. primary completion date June 30, 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 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c >8% - Active eating disorder

Study Design


Related Conditions & MeSH terms


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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
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