Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study ID
NCT04883346
Phase
PHASE2
Status
Completed

Conditions

  • Obesity
  • Status Post Sleeve Gastrectomy

Eligibility Criteria

Sex
ALL
Age
12 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.

Study Details

Background: Metabolic Bariatric Surgery, including a surgery called vertical sleeve gastrectomy, is the most effective weight loss treatment for severe obesity. However, many adolescents who have this surgery still have obesity 1 year later or regain weight. Researchers want to see if a drug can help. Objective: To learn if liraglutide can help adolescents who still have obesity 1 year or more after vertical sleeve gastrectomy lose additional weight. Eligibility: Healthy adolescents ages 12-20.99 years who are 1-10 years post vertical sleeve gastrectomy and have a BMI of 30 kg/m2 or \>=95th percentile for age and sex. Design: Participants will be screened with: Medical history Physical exam Questionnaires about their mood and feelings about their weight Blood and urine tests Nutrition counseling. They will keep a diet log. A test where they view and respond to pictures of food Wrist accelerometer set-up. They will wear an accelerometer (a device like a watch) on their wrist for 14 days. It will measure their physical activity. Some screening tests will be repeated during the study. Participants will have an oral glucose tolerance test. They will ingest a sweet liquid. Blood samples will be taken. Participants will take liraglutide daily for 16 weeks. They will learn how to inject it under their skin. Participants will have a body scan to measure muscle and fat. Participants will be invited to eat as much as they want at a buffet meal at NIH. How much food they eat will be calculated. They will assess their appetite and mood before and after the meal. Participation will last for 7 months. Participants will have up to 7 study visits....

Key Dates

Start date
Jun 21, 2021
Status verified
May 2024
Primary completion
Mar 15, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    Treated with Liraglutide

Primary Outcome Measure

Cohen's d (the Standardized Mean Difference) [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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