A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis. Non-diabetics with IR are at risk, but can be difficult to diagnose.
A major problem with the use of IR as a predictor or marker of disease is the lack of a simple, robust test that can be used to quantify this parameter in a wide variety of clinical situations. The current 'gold standard' methods for measuring insulin sensitivity, such as the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly. Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may be less accurate and are not widely accepted.
详细描述
A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or females aged 18-65 years
- •Females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception.
- •Healthy normal or overweight control subjects or healthy obese subjects or subjects with T2DM.
排除标准
- •Clinically significant past or current medical conditions
- •Clinically significant abnormalities in vital signs or routine laboratory parameters
研究组 & 干预措施
Subjects in healthy normal and overweight control arm
Subjects in the Healthy Normal or Overweight Control Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily.
干预措施: rosiglitazone maleate (Drug)
Subjects in healthy obese with T2DM arm
Subjects who are in the Healthy Obese or T2DM Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily.
干预措施: rosiglitazone maleate (Drug)
结局指标
主要结局
Insulin resistance
时间窗: baseline and after 8 weeks of Rosiglitazone treatment
次要结局
- Insulin resistance(baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment)
- hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance(baseline, after 8 weeks treatment)
- Body composition(baseline & after 8 weeks treatment)