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

NCT01253928 | Unknown Phase 4

• 1 other identifier: 224/05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD

Keywords

body composition; insulin sensitivity; protein metabolism; pioglitazone

Outcome Measures

Primary Outcomes (3)

• Body composition

  Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.

  at the end of each treatment phase (which lasts 4 months)

• Insulin sensitivity

  Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.

  at the end of each treatment phase (which lasts 4 months)

• Protein metabolism

  Protein turnover will be determined by leucine infusion during the insulin glucose clamp

  at the end of each treatment phase (which lasts 4 months)

Study Arms (2)

Pioglitazone 45mg per day

ACTIVE COMPARATOR

Pioglitazone 45mg qd will be added to the current treatment

Drug: Pioglitazone

placebo

PLACEBO COMPARATOR

placebo qd will be added to current treatment

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

45mg qd for 4 months

Also known as: Actos 45mg P05W8

Pioglitazone 45mg per day; placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non diabetic individuals with ESRD, on hemodialysis or peritoneal dialysis for at least 3 months. Consent form signed -

You may not qualify if:

• No infectious complication 3 months prior to entry in the study.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Nephrology Service Department of Medicine CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 25330088 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Insulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anne Zanchi, MD

  CHUV Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 6, 2010
• Study Start: March 1, 2007
• Primary Completion: June 1, 2011
• Last Updated: December 6, 2010

Record last verified: 2007-02

Locations

CH (1)