Pioglitazone on Pancreatic Steatosis and Bone Health

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Drug: placebo; Drug: pioglitazone

• Registration Number: NCT00855010
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2017-08-01
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-14
• Last Update Submitted: 2017-11-14
• Results First Posted: 2017-12-13
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo pill	placebo	placebo pill once daily (look-alike pill which contains no active ingredients)
pioglitazone	pioglitazone	pioglitazone tablet 45 mg once daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Beta-cell Function	12 months	Changes in B-cell function as measured by acute insulin release to glucose (AIRg)
Hepatic Fat Content	12 months	Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Subcutaneous Fat Area	12 months	Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.
Visceral Fat Area	12 months	Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
Bone Mineral Density	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.
Disposition Index	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

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States