Effects of Metformin on Body Weight, Composition and Metabolic Derangements in Obese Children. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo
研究概览
简要总结
This study expects to evaluate the use of metformin in the management of obese children. Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had been shown in the investigators previous work.
This study will look at the effect of metformin on changes in insulin resistance, fatty liver state, body fat content, BMI and other metabolic derangement.
详细描述
- General objective To study the prevalence of Non Communicable Disease (NCD) related metabolic derangements among obese children and assess the outcome of two different management (metformin vs placebo alongside dietary and physical activity changes) modalities among 8 to16 year old obese children living in Negombo educational division of Negambo educational zone of Gampaha district in Sri Lanka.
1.1 Specific objectives
- To study the prevalence of obesity related metabolic derangements among obese children.
- To compare the effectiveness of the use of metformin vs placebo in the change of fat content and BMI among obese children.
- To compare the effectiveness in the use of metformin vs placebo in the reversal of insulin resistance and metabolic derangements among obese children.
2 Methods 2.1 Study design A double blind randomized prospective placebo control study
2.2 Subjects and Study setting Obese (more than +2 Standard Deviation (SD) of BMI to age on World Health Organization (WHO) standards) school children from Negombo educational zone of district of Gampaha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese children (based on >+2SD of BMI to age on WHO 2007 standards)
排除标准
- •Children not of Sri Lankan origin
- •Children who are not planning to live in Sri Lanka during the next one year
- •Children with a secondary underlying cause for the overweight/obesity
研究组 & 干预措施
Metformin
8-10.99 year old children received metformin. Initially children given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week which increased to 500mg twice daily for a week and then to 1g twice daily. The medication was continued for 12 months.
干预措施: Metformin (Drug)
Placebo
A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above.
Metformin and placebo is manufactured by the State Pharmaceutical Manufacturing Corporation (SPMC)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo
时间窗: One year
BMI and Percentage Fat Mass SDS was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.
次要结局
- Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo(One year)
- Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo(One year)
- Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo(One year)
- Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo(One year)
研究者
Pujitha Wickramasinghe
Professor in Paediatrics
University of Colombo