Renal and Hormonal Effects of Pioglitazone

Phase 4

Completed

• Conditions: Diabetes; Hypertension
• Interventions: Drug: Pioglitazone; Drug: Metformin

• Registration Number: NCT01090752
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

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 Timeline

• Study Start: 2005-10
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2009-01
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Results First Submitted: 2010-03-24
• Results First Submitted QC: 2010-03-24
• Last Update Submitted: 2010-03-24
• Results First Posted: 2010-04-08
• Last Update Posted: 2010-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pioglitazone	Pioglitazone	placebo-controlled, randomized, cross-over study
Pioglitazone	Metformin	placebo-controlled, randomized, cross-over study
Metformine	Metformin	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effects of Pioglitazone on Salt Sensitivity	2009

Trial Locations

Locations (1)

Pechère-Bertschi Antoinette; 🇨🇭 Geneva, Switzerland