The Effect of Rosiglitazone on Ischemia-reperfusion-injury Using Annexin A5 Scintigraphy.

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: GlaxoSmithKline
• Treatments: Annexin A5; Rosiglitazone

Criteria

Inclusion Criteria:

• At least 3 features of the metabolic syndrome (AHA/NHLBI).

• Willing and able to provide a signed and dated written informed consent.

• Men or postmenopausal women aged between 20 and 70 years.

Exclusion Criteria:

• Fasting glucose > 7,0 mmol/L or the use of hypoglycaemic agents. If fasting plasma glucose is between 6.1 and 7,0 mmol/L, an oral 75 g glucose test will be performed to exclude diabetes mellitus.

• Exposure to a PPAR-g agonist during the last 4 months or a documented significant hypersensitivity to a PPAR-g agonist.

• Participant in another study.

• Angina or heart failure (NYHA I-IV).

• Clinically significant liver disease (3 times the upper normal limit of ALAT, ASAT, AF, γGT or LDH)

• Clinically significant anemia (male Hb < 6,9 mmol/L, female < 6,25 mmol/L)

• Creatinin clearance < 40 mL/min

• Alcohol or drug abuse.

• Any physical inability to perform the exercise protocol.

• Administration of any radio pharmacon for research purposes in the previous 5 years.