Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Left Ventricular Circumferential Strain change after a six-month course of Metformin.
研究概览
简要总结
It has been shown that asymptomatic obese adolescents can demonstrate abnormal regional myocardial contraction, with preserved global cardiac function. Metformin has been shown to decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance, but the mechanism of cardiovascular protection is unknown.
The purpose of this study is to evaluate the reversibility of subclinical cardiovascular abnormalities in obese adolescents with insulin resistance after a six-month course of Metformin. The investigators hypothesized that the beneficial effects of Metformin will be progressive and sustained after six months of therapy.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents 12 to 17 years old under clinical care at the UCSF WATCH clinic
- •Body mass index> 95th percentile for age and gender according to the Centers for Disease Control and Prevention 2000 growth charts for the United States
- •Insulin resistant after 6 months of healthy diet and exercise
- •Able to understand the assent form
排除标准
- •Patients with known cardiac disease
- •Patients with contraindications to metformin as listed below:
- •Renal disease or renal (serum creatinine levels ≥1.5 mg/dL for males, and ≥1.4 mg/dL for females;
- •Known hypersensitivity to Metformin;
- •Acute or chronic metabolic acidosis;
- •Patients with contraindications to MRI including:
- •Cardiac pacemaker;
- •Claustrophobia;
- •Metallic foreign body in the eye,
- •Aneurysm clip in the brain
- •Pregnancy;
- •Patients who could not stay still for 30 minutes within the MRI scanner due to other reasons besides claustrophobia
研究组 & 干预措施
Metformin, Insulin Resistance, Cardiac Function,
Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.
干预措施: Metformin (Drug)
结局指标
主要结局
Left Ventricular Circumferential Strain change after a six-month course of Metformin.
时间窗: 6 months
Circumferential strain will be measured by cardiac MRI before and after the treatment. Change in circumferential strain (measured as percentage from end-diastolic wall thickness) from baseline is the main outcome of this study. We hypothesize that abnormal baseline circumferential stain will increase and reach normal values after Metformin treatment. We hypothesized that the beneficial effects of Metformin will be progressive and sustained.
次要结局
未报告次要终点