Diabetes Mellitus, Type 2
Conditions
Keywords
total body water, T2DM,, Healthy Obese,, Insulin Resistance,, Rosiglitazone maleate,, Glucose Disposal,, hyperinsulinemic-euglycemic clamp,
Brief summary
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
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).
Interventions
Rosiglitazone tablets 4 mg dose will be administered orally by subjects
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin resistance | baseline and after 8 weeks of Rosiglitazone treatment |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed