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

Primary Purpose

ESRD

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ESRD focused on measuring body composition, insulin sensitivity, protein metabolism, pioglitazone

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Nephrology Service Department of Medicine CHUVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pioglitazone 45mg per day

placebo

Arm Description

Pioglitazone 45mg qd will be added to the current treatment

placebo qd will be added to current treatment

Outcomes

Primary Outcome Measures

Body composition
Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.
Insulin sensitivity
Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.
Protein metabolism
Protein turnover will be determined by leucine infusion during the insulin glucose clamp

Secondary Outcome Measures

Full Information

First Posted
December 3, 2010
Last Updated
December 3, 2010
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT01253928
Brief Title
Pioglitazone, Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD
Official Title
Effects of Pioglitazone on Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD Non Diabetic Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD
Keywords
body composition, insulin sensitivity, protein metabolism, pioglitazone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone 45mg per day
Arm Type
Active Comparator
Arm Description
Pioglitazone 45mg qd will be added to the current treatment
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo qd will be added to current treatment
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
Actos 45mg P05W8
Intervention Description
45mg qd for 4 months
Primary Outcome Measure Information:
Title
Body composition
Description
Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.
Time Frame
at the end of each treatment phase (which lasts 4 months)
Title
Insulin sensitivity
Description
Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.
Time Frame
at the end of each treatment phase (which lasts 4 months)
Title
Protein metabolism
Description
Protein turnover will be determined by leucine infusion during the insulin glucose clamp
Time Frame
at the end of each treatment phase (which lasts 4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Zanchi, MD
Organizational Affiliation
CHUV Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Service Department of Medicine CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Zanchi, MD
Phone
41 21 314 11 54
Email
azanchidel@hotmail.com
First Name & Middle Initial & Last Name & Degree
Anne Zanchi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25330088
Citation
Zanchi A, Tappy L, Le KA, Bortolotti M, Theumann N, Halabi G, Gauthier T, Mathieu C, Tremblay S, Bertrand PC, Burnier M, Teta D. Pioglitazone improves fat distribution, the adipokine profile and hepatic insulin sensitivity in non-diabetic end-stage renal disease subjects on maintenance dialysis: a randomized cross-over pilot study. PLoS One. 2014 Oct 16;9(10):e109134. doi: 10.1371/journal.pone.0109134. eCollection 2014.
Results Reference
derived

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

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