Status:
COMPLETED
The Effect of Rosiglitazone on Ischemia-reperfusion-injury Using Annexin A5 Scintigraphy.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Ischemia-Reperfusion Injury
The Metabolic Syndrome
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
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 wou...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00405015
Start Date
April 1 2007
End Date
October 1 2008
Last Update
August 24 2010
Active Locations (1)
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1
Clinical research Center Nijmegen
Nijmegen, Netherlands, 6500 HB