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Sponsors and Collaborators: |
Imperial College London GlaxoSmithKline |
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Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00481429 |
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:
Condition | Intervention |
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Diabetes Mellitus, Type 2 |
Drug: Rosiglitazone |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2010 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Contact: Robert I Hughes, BSc MBBS | 020 8383 2043/ 07810 642747 | r.hughes@imperial.ac.uk |
Contact: Martin R Wilkins, MD FRCP | 0208 383 2049 | m.wilkins@imperial.ac.uk |
United Kingdom | |
Imperial College London - Hammersmith Campus | |
London, United Kingdom, W12 ONN | |
Ealing Hospital | |
London, United Kingdom, UB1 3HW | |
Charing Cross Hospital | |
London, United Kingdom, W6 8RF | |
Addenbrooke's Hospital | |
Cambridge, United Kingdom, CB2 2GG |
Principal Investigator: | Martin R Wilkins, MD FRCP | Imperial College London |
Study ID Numbers: | cro700 |
Study First Received: | May 31, 2007 |
Last Updated: | May 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00481429 |
Health Authority: | United Kingdom: Research Ethics Committee |
Biomarker Glitazone Diabetes |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Rosiglitazone |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |