Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Effect of Metformin on body weight change
研究概览
简要总结
Obesity is a chronic disease of global public health concern, contributing to cardiovascular disease, type 2 diabetes and certain cancers. Currently approved anti-obesity drugs and surgery are expensive and not readily available in Nigeria.
Metformin, approved for type 2 diabetes, has been shown to promote weight loss among obese patients in high income countries. However, metformin's effects have not yet been demonstrated in Black African populations, which may have different genetic and environmental predispositions to obesity and to the effect of metformin. This blinded, placebo-controlled, randomized trial is determining the effect of metformin on weight loss, cardiovascular disease risk and insulin resistance in Black Nigerians.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinded Pharmacist
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Obesity (defined as body mass index ≥ 30kg/m2),
- •Fasting plasma glucose (<7.0mmol/L)
- •No medical treatment for weight control in the previous 12 months
- •No participation in a current clinical trial
排除标准
- •• Obesity (defined as body mass index ≥ 30kg/m2),
- •Fasting plasma glucose (<7.0mmol/L)
- •No medical treatment for weight control in the previous 12 months
- •No participation in a current clinical trial
研究组 & 干预措施
Treatment arm
Metformin 500mg extended release tablets taken once daily to a maximum dose of 1500mg daily
干预措施: Metformin (Drug)
Control arm
Identical-looking placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Metformin on body weight change
时间窗: 24 months
Determine percent change in body weight in kilograms and height in meters which will be combined to report BMI in kg/m2 among the treatment arm and compared to the control arm.
Effect of Metformin on Cardiovascular risk
时间窗: 24 months
Determine percent change in the 10 year Framingham risk score for cardiovascular disease among the treatment arm and compare with the control arm.
Effect of Metformin on insulin resistance in non-diabetics
时间窗: 24 months
Determine percent change in the insulin resistance indices using Homeostatic model assessment (HOMA) among the treatment arm and compare to the control arm.
Effect of metformin on waist circumference change
时间窗: 24 months
Determine the percent change in waist circumference measured in cm at baseline and final readings among the treatment arm and compared to the control arm.
Effect of metformin on waist-to-hip circumference change
时间窗: 24 months
Determine the percent change in waist circumference measured in cm, and hip circumference measured in cm, which will be combined to report waist-to-hip circumference ratio change among the treatment arm and compared to the control arm.
次要结局
- Safety of Metformin extended release tablet taken daily(24 months)
- Percent drug compliance to Metformin extended release taken once daily.(24 months)
研究者
Ifeyinwa Nnakenyi
Consultant Chemical Pathologist and Metabolic Physician
University Of Nigeria Teaching Hospital