Renal and Hormonal Effects of Pioglitazone

NCT01090752 | Completed Phase 4 Results

• 1 other identifier: FDAAA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension

Keywords

diabetes; blood pressure; pioglitazone; sodium; insulin resistance, renal function, sodium, pioglitazone

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Effects of Pioglitazone on 24h Blood Pressure Control

  24 hour blood pressure measurements were performed after each treatment/diet phase

  march 2009

Secondary Outcomes (1)

• Effects of Pioglitazone on Salt Sensitivity

  2009

Study Arms (2)

Pioglitazone

PLACEBO COMPARATOR

placebo-controlled, randomized, cross-over study

Drug: Pioglitazone; Drug: Metformin

Metformine

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Actos

Pioglitazone

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

Also known as: Glucophage, Glumetza, Fortamet, Riomet

Metformine; Pioglitazone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II Diabetes
• Hypertension

You may not qualify if:

• Cardiac or renal diseases
• Anaemia
• Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Pechère-Bertschi Antoinette

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

• Zanchi A, Pechere-Bertschi A, Burnier M, Bonny O. Effects of pioglitazone on renal calcium excretion. J Clin Endocrinol Metab. 2011 Sep;96(9):E1482-5. doi: 10.1210/jc.2011-0373. Epub 2011 Jul 13.

  PMID: 21752899 DERIVED

• Zanchi A, Maillard M, Jornayvaz FR, Vinciguerra M, Deleaval P, Nussberger J, Burnier M, Pechere-Bertschi A. Effects of the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone on renal and hormonal responses to salt in diabetic and hypertensive individuals. Diabetologia. 2010 Aug;53(8):1568-75. doi: 10.1007/s00125-010-1756-2. Epub 2010 Apr 23.

  PMID: 20414637 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Insulin Resistance

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Limitations and Caveats

The sample size may seem small but the cross over design of the study increased the statistical power. Each of 16 individuals was examined 4 times after the 4 different phases (pioglitazone-low salt, and high salt, placebo low salt and high salt).

Results Point of Contact

• Title: Zanchi Anne, MD
• Organization: University Hospital Geneva and Lausanne, Switzerland

azanchidel@hotmail.com

0041213140775

Study Officials

• Antoinette Pechere-Bertschi, MD

  University Hospital, Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 22, 2010
• Study Start: October 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 8, 2010
• Results First Posted: April 8, 2010

Record last verified: 2009-01

Locations

CH (1)