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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Centre Hospitalier Universitaire Vaudois.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01253928
First received: December 3, 2010
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
ESRD
 Drug: Pioglitazone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone on Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD Non Diabetic Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Body composition [ Time Frame: at the end of each treatment phase (which lasts 4 months) ] [ Designated as safety issue: No ]
    Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.

  • Insulin sensitivity [ Time Frame: at the end of each treatment phase (which lasts 4 months) ] [ Designated as safety issue: No ]
    Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.

  • Protein metabolism [ Time Frame: at the end of each treatment phase (which lasts 4 months) ] [ Designated as safety issue: No ]
    Protein turnover will be determined by leucine infusion during the insulin glucose clamp


Estimated Enrollment: 16
Study Start Date: March 2007
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone 45mg per day
Pioglitazone 45mg qd will be added to the current treatment
 Drug: Pioglitazone
45mg qd for 4 months
Other Name: Actos 45mg P05W8
Placebo Comparator: placebo
placebo qd will be added to current treatment
 Drug: Pioglitazone
45mg qd for 4 months
Other Name: Actos 45mg P05W8

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253928

Locations
Switzerland
Nephrology Service Department of Medicine CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Anne Zanchi, MD     41 21 314 11 54     azanchidel@hotmail.com    
Principal Investigator: Anne Zanchi, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Anne Zanchi, MD CHUV Lausanne
  More Information

No publications provided

Responsible Party: Anne Zanchi MD, CHUV
ClinicalTrials.gov Identifier: NCT01253928     History of Changes
Other Study ID Numbers: 224/05
Study First Received: December 3, 2010
Last Updated: December 3, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
body composition
insulin sensitivity
protein metabolism
pioglitazone

Additional relevant MeSH terms:
Kidney Failure, Chronic
Insulin Resistance
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013