Pioglitazone on Pancreatic Steatosis and Bone Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00855010
First received: February 27, 2009
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Obesity
Type 2 Diabetes
Drug: pioglitazone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

Resource links provided by NLM:


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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pioglitazone
pioglitazone tablet 45 mg once daily
Drug: pioglitazone
pioglitazone 45 mg daily
Other Name: Actos
Placebo Comparator: placebo pill
placebo pill once daily (look-alike pill which contains no active ingredients)
Drug: placebo
one daily
Other Name: Placebo tablet resembling pioglitazone 45 mg.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fat level in the pancreas above 4% (measurement done by us with an MRI)
  • English speaker
  • over 21 years old

Exclusion Criteria:

  • contraindication to MRI
  • anemia
  • pregnancy or desire to conceive
  • use of unapproved medications
  • prior pancreatic disease
  • use of more then 2 alcoholic drinks every day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00855010     History of Changes
Obsolete Identifiers: NCT00896116
Other Study ID Numbers: 112008-047, 1K23RRO24470-01
Study First Received: February 27, 2009
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Pioglitazone
prediabetes
diabetes
obesity
Pancreatic fat

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014