Pioglitazone on Pancreatic Steatosis and Bone Health

November 14, 2017 updated by: Ildiko Lingvay, University of Texas Southwestern Medical Center

Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pioglitazone
pioglitazone tablet 45 mg once daily
Drug: pioglitazone
pioglitazone 45 mg daily
Other Names:
  • Actos
Placebo Comparator: placebo pill
placebo pill once daily (look-alike pill which contains no active ingredients)
Drug: placebo
one daily
Other Names:
  • Placebo tablet resembling pioglitazone 45 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic Fat Content
Time Frame: 12 months
Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
12 months
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)
Time Frame: 12 months
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
12 months
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
Time Frame: 12 months
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta-cell Function
Time Frame: 12 months
Changes in B-cell function as measured by acute insulin release to glucose (AIRg)
12 months
Hepatic Fat Content
Time Frame: 12 months
Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
12 months
Subcutaneous Fat Area
Time Frame: 12 months
Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.
12 months
Visceral Fat Area
Time Frame: 12 months
Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
12 months
Bone Mineral Density
Time Frame: 12 months
Areal Bone Mineral Density at the L2-L4 antero-posterior lumbar spine, left femoral neck and total hip were measured by DXA scan using a Hologic Discovery Instrument scanner.
12 months
Disposition Index
Time Frame: 12 months
Disposition index is a measure of insulin secretion multiplied by insulin sensitivity, both derived from intravenous glucose tolerance test. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112008-047
  • 1K23RRO24470-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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