Glitazones and Endothelial Function (GATE)
|ClinicalTrials.gov Identifier: NCT00203632|
Recruitment Status : Terminated (Terminated at 50% enrollment due to recent concerns about rosiglitazone)
First Posted : September 20, 2005
Last Update Posted : November 3, 2008
The purpose of the study is to determine if the addition of rosiglitazone to subjects with fair glucose control on other oral agents improves endothelial function, a surrogate marker of vascular health.
It is hypothesized that improving whole body insulin sensitivity with combination therapy including rosiglitazone will restore the vascular actions of insulin and improve endothelium-dependent vasomotion more effectively than placebo in patients with diabetes mellitus.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: rosiglitazone/placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Trial of the Effect of Rosiglitazone as Add on to Metformin Therapy on Endothelial Function in Subjects With Type II DM|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||October 2007|
- The primary end-point of the study is the percent change in forearm blood flow to acetylcholine in patients randomized to rosiglitazone compared with placebo.
- Secondary end-points include (i) the percent change in forearm blood flow to verapamil and the absolute change to both acetylcholine and verapamil and (ii) the relationship between HOMA-IR, CRP and endothelial function.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203632
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Todd J Anderson, MD||University of Calgary|
|Study Chair:||Subodh Verma, MD, PhD||University of Toronto|