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Clinical Trial Details

Trial ID: L3825
Source ID: NCT00855010
Associated Drug: Pioglitazone
Title: Pioglitazone on Pancreatic Steatosis and Bone Health
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00855010/results
Conditions: Obesity|Type 2 Diabetes
Interventions: DRUG: pioglitazone|DRUG: placebo
Outcome Measures: 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|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: Beta-cell Function, Changes in B-cell function as measured by acute insulin release to glucose (AIRg), 12 months|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|Subcutaneous Fat Area, Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level., 12 months|Visceral Fat Area, Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level., 12 months|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|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
Sponsor/Collaborators: Sponsor: University of Texas Southwestern Medical Center | Collaborators: National Institutes of Health (NIH)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-02
Completion Date: 2013-12
Results First Posted: 2017-12-13
Last Update Posted: 2017-12-13
Locations: UT Southwestern Medical Center, Dallas, Texas, 75390, United States
URL: https://clinicaltrials.gov/show/NCT00855010