Pioglitazone on Pancreatic Steatosis and Bone Health
|ClinicalTrials.gov Identifier: NCT00855010|
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Type 2 Diabetes||Drug: pioglitazone Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Pioglitazone on Pancreatic Steatosis and Bone Health|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
pioglitazone tablet 45 mg once daily
pioglitazone 45 mg daily
Other Name: Actos
Placebo Comparator: placebo pill
placebo pill once daily (look-alike pill which contains no active ingredients)
Other Name: Placebo tablet resembling pioglitazone 45 mg.
- Pancreatic Fat Content [ Time Frame: 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) [ Time Frame: 12 months ]Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
- Bone Turnover Marker - Plasma 25-hydroxyvitamin D [ Time Frame: 12 months ]Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
- Beta-cell Function [ Time Frame: 12 months ]Changes in B-cell function as measured by acute insulin release to glucose (AIRg)
- Hepatic Fat Content [ Time Frame: 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 [ Time Frame: 12 months ]Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.
- Visceral Fat Area [ Time Frame: 12 months ]Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
- Bone Mineral Density [ Time Frame: 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 [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855010
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|