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.
Study Type
OBSERVATIONAL
Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
Addenbrooke's Hospital
Cambridge, United Kingdom
Ealing Hospital
London, United Kingdom
Imperial College London - Hammersmith Campus
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
The performance of baseline biochemical biomarkers in plasma and urine in distinguishing patients who respond to rosiglitazone from those that do not, as classified by a change in HbA1C at 12 weeks.
Time frame: 12 weeks
Variability in baseline levels of key biochemical markers in diabetic patients.
Time frame: 12 weeks
Effect of treatment on a variety of other novel potential predictive biomarkers and markers of insulin sensitisation in diabetic patients.
Time frame: 12 weeks
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