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Sponsors and Collaborators: |
University of Calgary GlaxoSmithKline |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00203632 |
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 | Intervention | Phase |
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Diabetes Mellitus |
Drug: rosiglitazone/placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Trial of the Effect of Rosiglitazone as Add on to Metformin Therapy on Endothelial Function in Subjects With Type II DM |
Enrollment: | 40 |
Study Start Date: | September 2003 |
Study Completion Date: | October 2007 |
The vascular endothelium has emerged as a critical determinant of cardiovascular health and disease, and improving endothelial function is an important target for therapy. Accumulating evidence suggest that insulin resistance in patients with diabetes and the metabolic syndrome may impair endothelial function, uncovering a proinflammatory, and proatherosclerotic vascular phenotype. The GATE study (Glitazones And The Endothelium) is a randomized, double blind study to evaluate the effects of rosiglitazone vs. placebo on endothelial function when employed as an add-on therapy in diabetic patients currently treated with oral therapy. We hypothesize that the PPAR-gamma agonist rosiglitazone, will improve endothelium-dependent vasodilatation, and that this effect will be related to improvements in insulin sensitivity, with concomitant reductions in whole body insulin resistance.
Furthermore, the beneficial effects of rosiglitazone will be additive to existing oral therapies that may modulate endothelial function, such as metformin. Since endothelial dysfunction plays a pivotal role in the development and progression of atherosclerosis, these studies may provide the rationale and impetus for aggressive treatment of insulin resistant patients with glitazone therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
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 |
Study ID Numbers: | TPD 084385 |
Study First Received: | September 13, 2005 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00203632 History of Changes |
Health Authority: | Canada: Health Canada |
diabetes mellitus endothelium thiazolidinediones atherosclerosis |
Atherosclerosis Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus 2,4-thiazolidinedione |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Rosiglitazone Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions |