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Renal and Hormonal Effects of Pioglitazone

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ClinicalTrials.gov Identifier: NCT01090752
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : April 8, 2010
Last Update Posted : April 8, 2010
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Hypertension Drug: Pioglitazone Drug: Metformin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : October 2005
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 :
  1. Effects of Pioglitazone on Salt Sensitivity [ Time Frame: 2009 ]


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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.

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

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 Posted: March 22, 2010    Key Record Dates
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