Rosiglitazone and Insulin Resistance in Renally Impaired Patients

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to participate in this metabolic study.

The primary aim of this study is to determine the effect of rosiglitazone on insulin resistance in non-obese patients with non-diabetic stage 4 CKD.

Secondary end points are the effects on inflammation (hsCRP), lipid profile, bone density and body composition.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Rosiglitazone

Criteria

Inclusion Criteria:

• CKD stage 4

• BMI ≤ 30

• Fasting glucose < 7 mmol/l

Exclusion Criteria:

Exclusion of patients will take place in case of:

• A diagnosis of diabetes mellitus for which the patient uses insulin

• Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period

• Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator

• Allergy for PPAR's

• Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status)

• Use of immunosuppressant agents

• History of renal transplant

• Hepatic insufficiency (defined as transaminase concentrations above > 2.5 times the upper limit of normal for the laboratories)

• A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week

• For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients