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
- Conditions
- Metabolic syndromeinsulin resistance syndrome1002859310012653
- Registration Number
- NL-OMON30227
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
1). At least 3 features of the metabolic syndrome (AHA/NHLBI) (10)
2). Willing and able to provide a signed and dated written informed consent.
3). Male and postmenopausal female subjects aged between 20 and 70 years
1). 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.
2). Exposure to a PPAR-g agonist during the last 4 months or a documented significant hypersensitivity to a PPAR-g agonist.
3). Participant in another study.
4). Angina or heart failure (NYHA I-IV).
5). Clinically significant liver disease (3 times the upper normal limit of ALAT, ASAT, AF, γGT or LDH)
6). Clinically significant anaemia (male Hb < 6,9 mmol/L, female < 6,25 mmol/L)
7). Creatinin clearance < 40 mL/min
8). Alcohol or drug abuse.
9). Any physical inability to perform the exercise protocol.
10). Administration of any radiotracer for research purposes during the previous 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Annexin targeting in the thenar muscle after ischemic exercise. The primary<br /><br>analysis is the difference in annexin targeting following 8 weeks of treatment<br /><br>with rosiglitazone 4 mg bd or placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The effect of rosiglitazone as compared to placebo on the HOMA-index.</p><br>