drugset / Trial / NCT01253928

Pioglitazone, Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD

NCT01253928

Phase 4 Unknown 16 enrolled Centre Hospitalier Universitaire Vaudois
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2007-03
Primary completion
2011-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pioglitazone Small molecule 45 mg