Viewing Study NCT00481429



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00481429
Status: WITHDRAWN
Last Update Posted: 2019-07-10
First Post: 2007-05-31

Brief Title: Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
Sponsor: Imperial College London
Organization: Imperial College London

Study Overview

Official Title: Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
Status: WITHDRAWN
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Unable to recruit enough participants
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None