Pioglitazone on Pancreatic Steatosis and Bone Health

Obesity Clinical Trial

Official title:

Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855010
• Other study ID #: 112008-047
• Secondary ID: 1K23RRO24470-01
• Status: Completed
• Phase: N/A
• First received: February 27, 2009
• Last updated: November 14, 2017
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: November 2017
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00896116

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Drug:
• pioglitazone
pioglitazone 45 mg daily
• placebo
one daily

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Bone Turnover Marker - Intact Parathyroid Hormone (PTH)	Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .	12 months
Primary	Bone Turnover Marker - Plasma 25-hydroxyvitamin D	Plasma 25-hydroxyvitamin D was determined by radioimmunoassay	12 months
Secondary	Beta-cell Function	Changes in B-cell function as measured by acute insulin release to glucose (AIRg)	12 months
Secondary	Hepatic Fat Content	Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.	12 months
Secondary	Subcutaneous Fat Area	Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.	12 months
Secondary	Visceral Fat Area	Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.	12 months
Secondary	Bone Mineral Density	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
Secondary	Disposition Index	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