Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in HbA1c value
研究概览
简要总结
To evaluate a standardized weight-loss program as treatment option for obesity and type 2 diabetes, changes in body composition and metabolic control are investigated in obese patients with diabetes.
详细描述
Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized weight-loss program (six weeks of formula diet, followed by the reintroduction of regular food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All subjects undergo bioelectrical impedance analyses to investigate body composition and magnet resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time points: first before the program, then at the end of the six weeks of formula diet and finally, at the end of the program after 15 weeks. Laboratory data are measured before and after the program.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •known type 2 diabetes
- •body-mass-index between 27 and 45 kg/m²
排除标准
- •treatment with incretin mimetic drugs < 3 month
- •pregnancy
- •immobilization
- •severe heart, liver or renal failure
- •eating disorder
- •alcoholism
结局指标
主要结局
Change in HbA1c value
时间窗: measured at week 0 and 15
次要结局
- Change in body-mass-index(measured at week 0, 6 and 15)
- Change in triglycerides(measured at week 0, 6 and 15)
- Change in cholesterol(measured at week 0, 6 and 15)
- Change in weight(measured at week 0, 6 and 15)
- Change in waist circumference(measured at week 0, 6 and 15)
- Change in hip circumference(measured at week 0, 6 and 15)
- Change in body composition(measured at week 0, 6 and 15)
- Change in fat fractions of abdominal organs(measured at week 0, 6 and 15)
- Change in visceral fat volume(measured at week 0, 6 and 15)
- Change in fasting glucose(measured at week 0 and 15)
- Change in fasting insulin(measured at week 0 and 15)
- Change in HDL cholesterol(measured at week 0, 6 and 15)
- Change in LDL cholesterol(measured at week 0, 6 and 15)
- Change in gamma-glutamyl transferase(measured at week 0, 6 and 15)
- Change in alkaline phosphatase(measured at week 0, 6 and 15)
- Change in 25-hydroxy-vitamine d3(measured at week 0 and 15)
- Change in alanine transaminase(measured at week 0, 6 and 15)
- Change in aspartate transaminase(measured at week 0, 6 and 15)
- Change in uric acid(measured at week 0, 6 and 15)
- Change in 1,25-dihydroxy-vitamine d3(measured at week 0 and 15)
- Change in plasma calcium(measured at week 0 and 15)
- Change in plasma phosphate(measured at week 0 and 15)
- Change in insulin-like growth factor-1(measured at week 0 and 15)
- Change in testosterone(measured at week 0 and 15)
- Change in sex hormone-binding globulin(measured at week 0 and 15)
- Change in quality of life(measured at week 0 and 15)
- Change in sleep quality(measured at week 0 and 15)
- Change in diet history(measured at week 0 and 15)