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.
Primary Outcome Measures:
- Insulin resistance [ Time Frame: baseline and after 8 weeks of Rosiglitazone treatment ]
Secondary Outcome Measures:
- Insulin resistance [ Time Frame: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment ]
- hepatic glucose output: baseline, after 8 weeks treatment
Insulin secretion from oral glucose tolerance [ Time Frame: baseline, after 8 weeks treatment ]
- Body composition [ Time Frame: baseline & after 8 weeks treatment ]
| Estimated Enrollment: |
36 |
| Study Start Date: |
July 2007 |
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).
Purpose
