Pioglitazone, Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD
NCT01253928 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2010-12-06
Summary
Non diabetic patients on renal replacement therapy are prone to changes in body composition with an increase in visceral fat and muscle wasting all favoured by the insulin resistant state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are the most powerful insulin sensitisers available in clinical practice which also have anti-inflammatory properties. Their use has been associated with significant and favourable changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest that glitazones may attenuate muscle wasting in renal failure.
The goal of this study was to examine in non diabetic ESRD patients the effects of pioglitazone on inulin sensitivity and protein metabolism as determined by the hyperinsulinemic euglycemic clamp and on changes in body composition as determined by anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined changes in abdominal visceral and sub-cutaneous fat.
Conditions
- ESRD
Interventions
- DRUG
-
Pioglitazone
45mg qd for 4 months
Sponsors & Collaborators
-
Centre Hospitalier Universitaire Vaudois
lead OTHER
Principal Investigators
-
Anne Zanchi, MD · CHUV Lausanne
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2011-06-30
Countries
- Switzerland
Study Locations
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