Renal and Hormonal Effects of Pioglitazone

Study Overview
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Brief Summary
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This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Detailed Description
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Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects. Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.

Official Title
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Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects

Conditions
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Diabetes, Hypertension

Intervention / Treatment
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* Drug: Pioglitazone
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type II Diabetes Hypertension Exclusion Criteria: Cardiac or renal diseases Anaemia Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Pioglitazone<br>placebo-controlled, randomized, cross-over study | Drug: Pioglitazone<br>* placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance<br>* Other names: Actos;Drug: Metformin<br>* placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance<br>* Other names: Riomet;|
| Placebo Comparator: Metformine<br>placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance | Drug: Metformin<br>* placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance<br>* Other names: Riomet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Pioglitazone on Renal Hemodynamics | At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF | 2008 | 
| Effects of Pioglitazone on Sodium and Lithium Clearances | At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances | 2007 | 
| Effects of Pioglitazone on 24h Blood Pressure Control | 24 hour blood pressure measurements were performed after each treatment/diet phase | march 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Pioglitazone on Salt Sensitivity |  | 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, blood pressure, pioglitazone, sodium, insulin resistance, renal function, sodium, pioglitazone