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

Study Overview
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Brief Summary
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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.

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

Conditions
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ESRD

Intervention / Treatment
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* Drug: Pioglitazone


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pioglitazone 45mg per day<br>Pioglitazone 45mg qd will be added to the current treatment | Drug: Pioglitazone<br>* 45mg qd for 4 months<br>* Other names: Actos 45mg P05W8;|
| Placebo Comparator: placebo<br>placebo qd will be added to current treatment | Drug: Pioglitazone<br>* 45mg qd for 4 months<br>* Other names: Actos 45mg P05W8;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body composition, insulin sensitivity, protein metabolism, pioglitazone