Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Cohen's d (the Standardized Mean Difference)
研究概览
简要总结
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....
详细描述
Study Description:
This trial is an open-label Phase II non-randomized pilot study conducted at the NIH Clinical Center to investigate the efficacy of daily subcutaneous injection of liraglutide, a glucagon-like peptide-1 (GLP1) analogue to promote reduction of body mass index (BMI) in adolescents who continue to have obesity (BMI (Bullet)30 or BMI >=95th percentile for age and sex) 1 year or more after vertical sleeve gastrectomy (SG). We hypothesize that administration of liraglutide will be associated with reduction in BMI in such adolescents.
Objectives:
Primary objective: To determine the effect size for the change in BMI of liraglutide 3.0 mg daily subcutaneously at 16 weeks in adolescents who have obesity after SG, in order to use the observed changes to determine the sample size of a subsequent randomized, controlled investigation.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Liraglutide
Treated with Liraglutide
干预措施: Liraglutide (Drug)
结局指标
主要结局
Cohen's d (the Standardized Mean Difference)
时间窗: 16 weeks
The change in BMI (kg/m2) measured from the baseline visit to the week 16 visit was used to inform a power calculation for a subsequent randomized controlled trial, assuming no change in BMI for the placebo group and the change in BMI that was found in this study at 16 weeks for the liraglutide group. There is no statistical analysis associated with this result.
次要结局
- Change in Fat Mass(16 weeks)
- Change in BMI(16 weeks)
- Change in Body Mass Index Z-score(16 weeks)
- Change in Body Weight(16 weeks)