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

ESRD Clinical Trial

Official title:

Effects of Pioglitazone on Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD Non Diabetic Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01253928
• Other study ID #: 224/05
• Status: Recruiting
• Phase: Phase 4
• First received: December 3, 2010
• Last updated: December 3, 2010
• Start date: March 2007

Study information

• Verified date: February 2007
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ESRD
• Insulin Resistance

Intervention

Drug:
• Pioglitazone
45mg qd for 4 months

Locations

Country	Name	City	State
Switzerland	Nephrology Service Department of Medicine CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.	at the end of each treatment phase (which lasts 4 months)	No
Primary	Insulin sensitivity	Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.	at the end of each treatment phase (which lasts 4 months)	No
Primary	Protein metabolism	Protein turnover will be determined by leucine infusion during the insulin glucose clamp	at the end of each treatment phase (which lasts 4 months)	No