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

V

Vaud University Hospital Center

Status and phase

Unknown
Phase 4

Conditions

ESRD

Treatments

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

Pioglitazone 45mg per day
Active Comparator group
Description:
Pioglitazone 45mg qd will be added to the current treatment
Treatment:
Drug: Pioglitazone
placebo
Placebo Comparator group
Description:
placebo qd will be added to current treatment
Treatment:
Drug: Pioglitazone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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