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

Phase 4

• Conditions: ESRD
• Interventions: Drug: Pioglitazone

• Registration Number: NCT01253928
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-02
• Study Start: 2007-03
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Last Update Submitted: 2010-12-03
• Study First Posted: 2010-12-06
• Last Update Posted: 2010-12-06
• Primary Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Non diabetic individuals with ESRD, on hemodialysis or peritoneal dialysis for at least 3 months. Consent form signed -

Exclusion Criteria

No infectious complication 3 months prior to entry in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pioglitazone 45mg per day	Pioglitazone	Pioglitazone 45mg qd will be added to the current treatment
placebo	Pioglitazone	placebo qd will be added to current treatment

Primary Outcome Measures

Name	Time	Method
Body composition	at the end of each treatment phase (which lasts 4 months)	Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.
Insulin sensitivity	at the end of each treatment phase (which lasts 4 months)	Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.
Protein metabolism	at the end of each treatment phase (which lasts 4 months)	Protein turnover will be determined by leucine infusion during the insulin glucose clamp

Trial Locations

Locations (1)

Nephrology Service Department of Medicine CHUV; 🇨🇭 Lausanne, Vaud, Switzerland