Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in BMI
研究概览
简要总结
The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.
Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.
详细描述
This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese adolescents defined as BMI greater than the 95th percentile for age and gender
- •Metformin naive subjects
排除标准
- •Elevated fasting plasma glucose ≥ 6.0 mmol/L
- •2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load
- •A1C > 6.0%
- •Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement
- •Pregnancy
- •Renal insufficiency (serum creatinine > the upper limit of normal)
- •Hepatic dysfunction (> 1.5 times the upper limit of normal for AST and ALT)
- •Latex Allergy
- •Hypersensitivity to metformin or its ingredients
- •Breast feeding
- •Subjects with a history of lactic acidosis
- •Abnormal creatinine clearance
- •HIV, HBV, and HCV infections
- •Drug and alcohol abuse
- •Severe mental disorders
- •Subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials
- •Participation in another clinical trial
- •Significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders
- •Malignant diseases
- •Previous exposure to any pharmaceutical antidiabetic agent
研究组 & 干预措施
Placebo, Standard exercise
Lifestyle intervention with placebo and standard exercise program
干预措施: Placebo Standard exercise (Behavioral)
Metformin, Standard exercise
Lifestyle intervention with metformin and standard exercise program.
干预措施: Metformin and standard exercise (Drug)
Metformin, Intensive exercise
Lifestyle intervention with metformin and intensive exercise
干预措施: Metformin Intensive exercise (Drug)
Placebo, Intensive exercise
Lifestyle intervention with placebo and intensive exercise program.
干预措施: Intensive exercise (Behavioral)
结局指标
主要结局
Reduction in BMI
时间窗: 2 years
次要结局
- Improvement in physical activity(2 years)
研究者
Cheryl
Dr Cheril Clarson
Lawson Health Research Institute