Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: rosiglitazone maleate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Clinically significant past or current medical conditions Clinically significant abnormalities in vital signs or routine laboratory parameters

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects in healthy normal and overweight control arm<br>Subjects in the Healthy Normal or Overweight Control Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily. | Drug: rosiglitazone maleate<br>* Rosiglitazone tablets 4 mg dose will be administered orally by subjects<br>|
| Experimental: Subjects in healthy obese with T2DM arm<br>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. | Drug: rosiglitazone maleate<br>* Rosiglitazone tablets 4 mg dose will be administered orally by subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance |  | baseline and after 8 weeks of Rosiglitazone treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total body water, T2DM,, Healthy Obese,, Insulin Resistance,, Rosiglitazone maleate,, Glucose Disposal,, hyperinsulinemic-euglycemic clamp,