Status:
COMPLETED
The Influence of Rosiglitazone on the Diuretic Effect of Furosemide and Amiloride
Lead Sponsor:
Radboud University Medical Center
Conditions:
Insulin Resistance
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
Thiazolidinedione derivates (TZD's) are Peroxisome-Proliferator-Activated-Receptor-γ agonists (PPARγ-agonists) and enhance insulin sensitivity. One of the side effects, however, is the fact that subje...
Detailed Description
This is a randomized, placebo-controlled, double-blind, single-centre, cross-over study with 4 weeks of wash out comparing placebo with rosiglitazone 4 mg bid for 9 weeks treatment periods. Randomizat...
Eligibility Criteria
Inclusion
- Healthy but with 2 features of the metabolic syndrome (AHA/NHLBI) (16)
- Willing and able to provide a signed and dated written informed consent.
- Male or female subject aged between 30 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 anaemia (male Hb \< 6,9 mmol/L, female \< 6,25 mmol/L)
- Creatinin clearance \< 40 mL/min
- Pregnancy, lactation
- Alcohol or drug abuse. Liquorice
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00285805
Start Date
February 1 2006
End Date
November 1 2006
Last Update
August 24 2010
Active Locations (1)
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1
Radboud University Nijmegen medical centre
Nijmegen, Netherlands, 6500 HB