Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
pioglitazone 45 mg daily
one daily
UT Southwestern Medical Center
Dallas, Texas, United States
Pancreatic Fat Content
Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Time frame: 12 months
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
Time frame: 12 months
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
Time frame: 12 months
Beta-cell Function
Changes in B-cell function as measured by acute insulin release to glucose (AIRg)
Time frame: 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.
Time frame: 12 months
Subcutaneous Fat Area
Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.
Time frame: 12 months
Visceral Fat Area
Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
Time frame: 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.
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Time frame: 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
Time frame: 12 months