Study Stopped
Terminated at 50% enrollment due to recent concerns about rosiglitazone
Glitazones and Endothelial Function (GATE)
A Trial of the Effect of Rosiglitazone as Add on to Metformin Therapy on Endothelial Function in Subjects With Type II DM
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus
Started Sep 2003
Typical duration for phase_3 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 3, 2008
October 1, 2008
September 13, 2005
October 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- All patients (both men and women) considered for participation in GATE study have to be non-insulin dependent diabetics (according to Canadian Diabetes Association criteria, namely a fasting serum glucose ≥ 7.0 mmol/L on two occasions, a casual glucose ≥ 11.1 mmol/l with symptoms, or a 2-h post-oral glucose tolerance test glucose of ≥ 11.1 mmol/l) with unsatisfactory glycemic control on oral therapy (HbA1c 6-10%).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Related Publications (1)
Hubacek J, Verma S, Shewchuk L, Ross SJ, Edwards A, Anderson TJ. Rationale and design of the Glitazones and the Endothelium (GATE) study: evaluation of rosiglitazone on endothelial function in patients with diabetes. Can J Cardiol. 2004 Dec;20(14):1449-53.
PMID: 15614340BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd J Anderson, MD
University of Calgary
- STUDY CHAIR
Subodh Verma, MD, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
September 1, 2003
Study Completion
October 1, 2007
Last Updated
November 3, 2008
Record last verified: 2008-10