Pioglitazone on Pancreatic Steatosis and Bone Health

This study is currently recruiting participants.

Verified by University of Texas Southwestern Medical Center, February 2009

First Received: February 27, 2009 Last Updated: March 2, 2009 History of Changes

Sponsors and Collaborators:	University of Texas Southwestern Medical Center National Institutes of Health (NIH)
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00855010

Purpose

Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.

Condition	Intervention
Obesity Impaired Glucose Tolerance Impaired Fasting Glucose Diabetes	Drug: pioglitazone Drug: placebo

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

Pancreatic fat content [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Bone turnover markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Beta-cell function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Hepatic fat content [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Subcutaneous fat area [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Visceral fat area [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Total body fat [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pioglitazone: Experimental pioglitazone tablets 45 mg once daily	Drug: pioglitazone pioglitazone 45 mg daily
sugar pill: Placebo Comparator sugar pill once daily	Drug: placebo one daily

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855010

Locations

United States, Texas
UT Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Sarmistha Sen 214-648-2779 ildiko.lingvay@utsouthwestern.edu
Contact: Ildiko Lingvay, MD, MPH, MSCS 214-648-2779 ildiko.lingvay@utsouthwestern.edu
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS
Sub-Investigator: Naim Maalouf, MD
Sub-Investigator: Lidia Szczepaniak, PhD

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	UT Southwestern Medical Center ( Ildiko Lingvay, MD, MPH, MSCS )
Study ID Numbers:	112008-047, 1K23RRO24470-01
Study First Received:	February 27, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00855010 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

prediabetes
diabetes
obesity
early diabetes

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Pioglitazone
Glucose Intolerance
Diabetes Mellitus
Prediabetic State
Overweight
Body Weight

Signs and Symptoms
Hypoglycemic Agents
Hyperglycemia
Nutrition Disorders
Overnutrition
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Obesity
Metabolic Diseases
Pioglitazone
Glucose Intolerance
Physiological Effects of Drugs
Overweight
Pharmacologic Actions

Body Weight
Signs and Symptoms
Hyperglycemia
Hypoglycemic Agents
Nutrition Disorders
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009