Health TrialsbyHealthPanel

Oxytocin for Weight Loss in Adolescents

ConditionsObesity, AdolescentOxytocin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-18
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxytocin nasal spray

    Drug

    24 IU nasal spray, 4 times per day for 12 weeks

  • Placebo

    Drug

    24 IU nasal spray, 4 times per day for 12 weeks

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: OxytocinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks

Secondary outcomes

1

Lean mass and Fat mass

Dual Energy Absorptiometry (DXA) will be used for measuring fat mass (kg) and lean mass (Kg)

Time frame
12 weeks
2

Fasting Resting Energy Expenditure (kCal)

Assessed by Indirect calorimetry

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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