An observational study in Diabetes Mellitus, Type 2, sponsored by Imperial College London. Withdrawn at 4 sites in United Kingdom. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Imperial College London · Observational
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:
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with type 2 diabetes attending clinic
Exclusion Criteria:
History of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT>2 times upper limit of normal range (ULN), bilirubin>1.5 time ULN.
History of renal disease or serum creatinine greater than 1.5 X ULN.
Rosiglitazone
Drug: Rosiglitazone
Diet control +/- metformin
Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
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
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Imperial College London