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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone 45mg per day | Active Comparator | Pioglitazone 45mg qd will be added to the current treatment |
|
| placebo | Placebo Comparator | placebo qd will be added to current treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | 45mg qd for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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.
-
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| Name | Affiliation | Role |
|---|---|---|
| Anne Zanchi, MD | CHUV Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Service Department of Medicine CHUV | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25330088 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |