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Clinical Trials/NL-OMON30227
NL-OMON30227
Not yet recruiting
Phase 2

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 - Rosiglitazone and ischemia-reperfusion-injury in humans

niversitair Medisch Centrum Sint Radboud0 sites12 target enrollmentTBD
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Conditionsinsulin resistance syndromeMetabolic syndrome1002859310012653

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
insulin resistance syndrome
Sponsor
niversitair Medisch Centrum Sint Radboud
Enrollment
12
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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