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Pioglitazone on Pancreatic Steatosis and Bone Health

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855010
First Posted: March 3, 2009
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Ildiko Lingvay, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Pancreatic fat content [ Time Frame: 12 months ]
  • Bone turnover markers [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Beta-cell function [ Time Frame: 12 months ]
  • Hepatic fat content [ Time Frame: 12 months ]
  • Subcutaneous fat area [ Time Frame: 12 months ]
  • Visceral fat area [ Time Frame: 12 months ]
  • Bone mineral density [ Time Frame: 12 months ]
  • Total body fat [ Time Frame: 12 months ]

Enrollment: 40
Study Start Date: February 2009
Study Completion Date: December 2013
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00855010


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institutes of Health (NIH)
  More Information

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
First Submitted: February 27, 2009
First Posted: March 3, 2009
Last Update Posted: November 15, 2017
Last Verified: November 2014

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

Additional relevant MeSH terms:
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs