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NCT Number: NCT01090752

Renal and Hormonal Effects of Pioglitazone

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

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pechère-Bertschi Antoinette

Geneva, Canton of Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pioglitazone

Drug

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: Actos

metformin

Drug

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 outcomes

  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 outcomes

  1. Effects of Pioglitazone on Salt Sensitivity

    Time frame: 2009

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • University of Lausanne Hospitals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 22, 2010
Registry last updated
Apr 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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