Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405015
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2006-11-28
Brief Title:
The Effect of Rosiglitazone on Ischemia-reperfusion-injury Using Annexin A5 Scintigraphy
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The Effect of Rosiglitazone on Ischemia-reperfusion-injury Using Annexin A5 Scintigraphy A Double Blind Placebo- Controlled Cross-over Study in Subjects With the Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Rosiglitazone reduces ischemia-reperfusion-injury in humans with insulin resistance
Detailed Description:
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 parametersendpoints 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
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 parametersendpoints 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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number 2006-006208-13 | None | None | None |