Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
Hypothesis:
A cluster of biochemical measurements (biomarkers) predict which diabetic patients will
respond to treatment with a therapeutic dose of rosiglitazone over a 12 week treatment
period.
Brief Summary:
The purpose of this study is to assess the predictive value of the biomarkers in diabetic
patients treated with a full dose of a thiazolidinedione (eg 4mg bid rosiglitazone) for 12
weeks.
Specifically - the questions asked are:
1. Do baseline measurements of a selected panel of biomarkers predict the patients'
response to rosiglitazone over 12 weeks?
2. How does the panel of biomarkers change over that 12 week treatment period?
Rosiglitazone (Avandia) is a medicine used to treat type 2 diabetes. It works by increasing
the sensitivity of body tissues to insulin.
This pilot study will examine the possibility that baseline biochemistry might predict the
response to rosiglitazone. The study will be conducted in males and the biomarkers of
interest measured by specific assays. In addition, since the biomarkers to be measured come
from body fat, interpretation of the data would be facilitated by accurate measurements of
changes in body fat mass during treatment and these data can be obtained from Echo-MRI scans.
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