A Phase 2 interventional study of rosiglitazone in Ischemia-Reperfusion Injury and The Metabolic Syndrome, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-08-24.
Sponsored by Radboud University Medical Center · Phase 2, Interventional, and Prevention
Cardiovascular disease is the leading cause of death in diabetic patients due to both a high event rate and a worse outcome. A pharmacological intervention that reduces ischemia-reperfusion-injury would improve the outcome of diabetic patients after a cardiovascular event. In the present study, we will use annexinA5 scintigraphy to address the following hypothesis:
Rosiglitazone reduces ischemia-reperfusion-injury in humans with insulin resistance.
Rationale: Cardiovascular disease is the leading cause of death in diabetic patients due to both a high event rate and a worse outcome. A pharmacological intervention that reduces ischemia-reperfusion-injury would improve the outcome of diabetic patients after a cardiovascular event. The thiazolidinedione derivatives are peroxisome proliferator-activated receptor-γ (PPARγ) ligands that are approved for the treatment of hyperglycemia in type 2 diabetes mellitus. Animal data suggest that PPARγ ligands can protect against ischemia-reperfusion-injury by improving insulin responsiveness. However, no human data on these beneficial effects are available. Recently, our group developed a human in vivo model to quantify ischemia-reperfusion-injury. In this model annexin A5 scintigraphy is used to visualize early and reversible cellular membrane changes that occur in the forearm skeletal muscle vascular bed after ischemic exercise. In the present study, we will use this approach to address the following hypothesis: Rosiglitazone reduces ischemia-reperfusion-injury in humans with insulin resistance, selected by using the criteria for the metabolic syndrome.
Study design: This is a single-center randomized, double blind, placebo-controlled crossover study with a washout period of 6 weeks.
Study population: Men and postmenopausal women, age 20-70 years with the metabolic syndrome.
Intervention: Every subject uses during 8 weeks rosiglitazone 4 mg bd and placebo bd. Week 8 and 22: assessment of ischemic-reperfusion injury with Technetium Annexin A5 Scintigraphy. Ischemic intervention: 10 minutes ischemia of the non-dominant arm with at the same time rhythmic contractions of the forearm and hand muscles.
Main study parameters/endpoints: Annexin targeting in the thenar muscle after ischemic exercise. The primary analysis is the difference in annexin targeting following 8 weeks of treatment with rosiglitazone 4 mg bd or placebo.
278 studies on the registry are indexed under Reperfusion Injury; 41 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 221 interventional studies indexed under Reperfusion Injury.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Placebo first
Drug: rosiglitazone
Rosiglitazone first
Drug: rosiglitazone
Rosiglitazone 4 mg bidaily for 8 weeks
Annexin targeting in the thenar muscle after ischemic exercise. The primary analysis is the difference in annexin targeting following 8 weeks of treatment with rosiglitazone 4 mg bd or placebo.
The effect of rosiglitazone as compared to placebo on the HOMA-index.
Changes in vital signs, body weight, clinical laboratory parameters and adverse events monitoring during the study.
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rosiglitazone
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