Renal and Hormonal Effects of Pioglitazone

University Hospital, Geneva16 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Hypertension

Interventions

PioglitazoneDRUG

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

MetforminDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pechère-Bertschi Antoinette

Geneva, Canton of Geneva, Switzerland

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 2007

Effects of Pioglitazone on 24h Blood Pressure Control

24 hour blood pressure measurements were performed after each treatment/diet phase

Time frame: march 2009

Secondary Outcomes

Effects of Pioglitazone on Salt Sensitivity

Time frame: 2009

Data from ClinicalTrials.gov

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