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Pioglitazone on Pancreatic Steatosis and Bone Health

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ClinicalTrials.gov Identifier: NCT00855010
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Obesity Type 2 Diabetes Drug: pioglitazone Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : February 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013


Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Bone Turnover Marker - Intact Parathyroid Hormone (PTH) [ Time Frame: 12 months ]
    Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .

  3. Bone Turnover Marker - Plasma 25-hydroxyvitamin D [ Time Frame: 12 months ]
    Plasma 25-hydroxyvitamin D was determined by radioimmunoassay


Secondary Outcome Measures :
  1. Beta-cell Function [ Time Frame: 12 months ]
    Changes in B-cell function as measured by acute insulin release to glucose (AIRg)

  2. 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.

  3. Subcutaneous Fat Area [ Time Frame: 12 months ]
    Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.

  4. Visceral Fat Area [ Time Frame: 12 months ]
    Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.

  5. 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.

  6. 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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 3, 2009    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017

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