Renal and Hormonal Effects of Pioglitazone

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090752
• Other study ID #: FDAAA
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2010
• Last updated: March 24, 2010
• Start date: October 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Drug:
• Pioglitazone
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
• 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

Locations

Country	Name	City	State
Switzerland	Pechère-Bertschi Antoinette	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	Effects of Pioglitazone on 24h Blood Pressure Control	24 hour blood pressure measurements were performed after each treatment/diet phase	march 2009	Yes
Secondary	Effects of Pioglitazone on Salt Sensitivity		2009	No