Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- To detect an association between insulin-induced weight gain and physical activity levels
研究概览
简要总结
The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus
Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.
详细描述
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus.
The aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 diabetes mellitus
- •age 18-85 years
- •Hba1c at baseline < 12.0%
- •written informed consent
排除标准
- •Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight
- •Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels
- •Excessive alcohol consumption (>20 g/day), and drug abuse
- •Use of thiazolidinedione derivatives (TZDs)
- •Pregnancy or intention to become pregnant during the study
结局指标
主要结局
To detect an association between insulin-induced weight gain and physical activity levels
时间窗: 1 year
次要结局
- To assess the relationship between insulin-induced weight gain and cardiovascular risk profile(1 year)