Pioglitazone on Pancreatic Steatosis and Bone Health
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|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|
|Obesity Type 2 Diabetes||Drug: pioglitazone Drug: placebo|
|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|
|Primary Completion Date :||December 2013|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|