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Pioglitazone on Pancreatic Steatosis and Bone Health

Primary Purpose

Obesity, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pioglitazone
placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Pioglitazone, prediabetes, diabetes, obesity, Pancreatic fat

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pioglitazone

placebo pill

Arm Description

pioglitazone tablet 45 mg once daily

placebo pill once daily (look-alike pill which contains no active ingredients)

Outcomes

Primary Outcome Measures

Pancreatic Fat Content
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)
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2009
Last Updated
November 14, 2017
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00855010
Brief Title
Pioglitazone on Pancreatic Steatosis and Bone Health
Official Title
Effect of Pioglitazone on Pancreatic Steatosis and Bone Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Pioglitazone, prediabetes, diabetes, obesity, Pancreatic fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pioglitazone
Arm Type
Experimental
Arm Description
pioglitazone tablet 45 mg once daily
Arm Title
placebo pill
Arm Type
Placebo Comparator
Arm Description
placebo pill once daily (look-alike pill which contains no active ingredients)
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
pioglitazone 45 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Placebo tablet resembling pioglitazone 45 mg.
Intervention Description
one daily
Primary Outcome Measure Information:
Title
Pancreatic Fat Content
Description
Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Time Frame
12 months
Title
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)
Description
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
Time Frame
12 months
Title
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
Description
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Beta-cell Function
Description
Changes in B-cell function as measured by acute insulin release to glucose (AIRg)
Time Frame
12 months
Title
Hepatic Fat Content
Description
Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Time Frame
12 months
Title
Subcutaneous Fat Area
Description
Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.
Time Frame
12 months
Title
Visceral Fat Area
Description
Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
Time Frame
12 months
Title
Bone Mineral Density
Description
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.
Time Frame
12 months
Title
Disposition Index
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Pioglitazone on Pancreatic Steatosis and Bone Health

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