Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
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 7 study visits....
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)