ESRD
Conditions
Keywords
body composition, insulin sensitivity, protein metabolism, pioglitazone
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.
Interventions
DRUGPioglitazone
45mg qd for 4 months
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 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. |
| Insulin sensitivity | 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. |
| Protein metabolism | at the end of each treatment phase (which lasts 4 months) | Protein turnover will be determined by leucine infusion during the insulin glucose clamp |
Countries
Switzerland
Outcome results
None listed