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

December 3, 2010 updated by: Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Nephrology Service Department of Medicine CHUV
        • Contact:
        • Principal Investigator:
          • Anne Zanchi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pioglitazone 45mg per day
Pioglitazone 45mg qd will be added to the current treatment
Drug: Pioglitazone
45mg qd for 4 months
Other Names:
  • Actos 45mg P05W8
Placebo Comparator: placebo
placebo qd will be added to current treatment
Drug: Pioglitazone
45mg qd for 4 months
Other Names:
  • Actos 45mg P05W8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 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.
at the end of each treatment phase (which lasts 4 months)
Insulin sensitivity
Time Frame: 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.
at the end of each treatment phase (which lasts 4 months)
Protein metabolism
Time Frame: at the end of each treatment phase (which lasts 4 months)
Protein turnover will be determined by leucine infusion during the insulin glucose clamp
at the end of each treatment phase (which lasts 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Anne Zanchi, MD, CHUV Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 3, 2010

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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