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

NCT ID: NCT01253928

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

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.

Detailed Description

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Conditions

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ESRD

Keywords

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body composition insulin sensitivity protein metabolism pioglitazone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pioglitazone 45mg per day

Pioglitazone 45mg qd will be added to the current treatment

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

45mg qd for 4 months

placebo

placebo qd will be added to current treatment

Group Type PLACEBO_COMPARATOR

Pioglitazone

Intervention Type DRUG

45mg qd for 4 months

Interventions

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Pioglitazone

45mg qd for 4 months

Intervention Type DRUG

Other Intervention Names

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Actos 45mg P05W8

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.

\-
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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CHUV

Principal Investigators

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Anne Zanchi, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV Lausanne

Locations

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Nephrology Service Department of Medicine CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Anne Zanchi, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25330088 (View on PubMed)

Other Identifiers

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224/05

Identifier Type: -

Identifier Source: org_study_id