Pioglitazone on Pancreatic Steatosis and Bone Health
Effect of Pioglitazone on Pancreatic Steatosis and Bone Health
2 other identifiers
interventional
42
1 country
1
Brief Summary
Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2009
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
December 13, 2017
CompletedDecember 13, 2017
November 1, 2017
4.8 years
February 27, 2009
August 1, 2017
November 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pancreatic Fat Content
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)
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
12 months
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
12 months
Secondary Outcomes (6)
Beta-cell Function
12 months
Hepatic Fat Content
12 months
Subcutaneous Fat Area
12 months
Visceral Fat Area
12 months
Bone Mineral Density
12 months
- +1 more secondary outcomes
Study Arms (2)
pioglitazone
EXPERIMENTALpioglitazone tablet 45 mg once daily
placebo pill
PLACEBO COMPARATORplacebo pill once daily (look-alike pill which contains no active ingredients)
Interventions
Eligibility Criteria
You may qualify if:
- Fat level in the pancreas above 4% (measurement done by us with an MRI)
- English speaker
- over 21 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ildiko Lingvay
- Organization
- UT Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MPH, MSCS
Study Record Dates
First Submitted
February 27, 2009
First Posted
March 3, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 13, 2017
Results First Posted
December 13, 2017
Record last verified: 2017-11