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Renal and Hormonal Effects of Pioglitazone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090752
First Posted: March 22, 2010
Last Update Posted: April 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Lausanne Hospitals
Information provided by:
University Hospital, Geneva
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Effects of Pioglitazone on Renal Hemodynamics [ Time Frame: 2008 ]
    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 ]
    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 ]
    24 hour blood pressure measurements were performed after each treatment/diet phase


Secondary Outcome Measures:
  • Effects of Pioglitazone on Salt Sensitivity [ Time Frame: 2009 ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 19, 2010
First Posted: March 22, 2010
Results First Submitted: March 24, 2010
Results First Posted: April 8, 2010
Last Update Posted: April 8, 2010
Last Verified: January 2009

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

Additional relevant MeSH terms:
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs