Effect of Pioglitazone on Pancreatic Steatosis and Bone Turnover

Summary

The study is a double blind, randomized controlled trial. The projected sample size for the study is 80 subjects with 40 in each group.

Study Procedures:
The following tests and/or evaluations will be undergone during the whole study:

Screening visit:
• Explain the research study, review and sign paperwork;
• Obtain contact and demographic information;
• Evaluate if the volunteers qualify for the study;
• This visit can be done over the phone or by volunteers personally coming to UT Southwestern Medical Center

Baseline visit:
• This visit requires 2 or 3 trips to our site. Great effort is made to have more than one procedure on the same day to minimize the trips taken by the volunteer.
• Detailed medical history;
• Physical exam;
• Vital signs;
• Blood draws to do various tests;
• Frequently samples intravenous glucose tolerance test: lasts approximately 3 hours;
• Magnetic resonance spectroscopy of liver, pancreas, heart, skeletal muscle and bone marrow;
• Bone density measurement (DEXA).

If the volunteers qualify for the study they will be randomized to either Pioglitazone 45 mg or Placebo daily.
After randomization a phone call will be scheduled after 2 weeks to check for pill compliance and recording any adverse events. The phone call can be either volunteer or investigator initiated. Thereafter there will be monthly patient interaction either through an office visit or phone call to ensure patient safety and adherence to study procedures.

Participant Eligibility

1. We will include both male and female patients, of all ethnicities.
2. Patients must be >21 yrs old, with pancreatic TG content above 4% and who fully understand and are willing to undergo study procedures, available for follow-up visits, understand and are willing to sign informed consent.
3. Subjects have to be willing to return for follow-up visits for the entire duration of the study.