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Renal and Hormonal Effects of Pioglitazone

This study has been completed.
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01090752
First received: March 19, 2010
Last updated: March 24, 2010
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes
Hypertension
 Drug: Pioglitazone
Drug: Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Effects of Pioglitazone on Renal Hemodynamics [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]
    At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF

  • Effects of Pioglitazone on Sodium and Lithium Clearances [ Time Frame: 2007 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: march 2009 ] [ Designated as safety issue: Yes ]
    24 hour blood pressure measurements were performed after each treatment/diet phase


Secondary Outcome Measures:
  • Effects of Pioglitazone on Salt Sensitivity [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pioglitazone
placebo-controlled, randomized, cross-over study
 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
Other Name: Actos
Drug: 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
Other Names:
  • Glucophage
  • Glumetza
  • Fortamet
  • Riomet
Placebo Comparator: Metformine
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
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
Other Names:
  • Glucophage
  • Glumetza
  • Fortamet
  • Riomet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090752

Locations
Switzerland
Pechère-Bertschi Antoinette
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
University of Lausanne Hospitals
Investigators
Study Director: Antoinette Pechere-Bertschi, MD Geneva University Hospital
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital Geneva
ClinicalTrials.gov Identifier: NCT01090752     History of Changes
Other Study ID Numbers: FDAAA
Study First Received: March 19, 2010
Results First Received: March 24, 2010
Last Updated: March 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospital, Geneva:
diabetes
blood pressure
pioglitazone
sodium
insulin resistance, renal function, sodium, pioglitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
 Cardiovascular Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013