Pioglitazone on Pancreatic Steatosis and Bone Health

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

Official Title
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Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Drug: pioglitazone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pioglitazone<br>pioglitazone tablet 45 mg once daily | Drug: pioglitazone<br>* pioglitazone 45 mg daily<br>* Other names: Actos;|
| Placebo Comparator: placebo pill<br>placebo pill once daily (look-alike pill which contains no active ingredients) | Drug: placebo<br>* one daily<br>* Other names: Placebo tablet resembling pioglitazone 45 mg.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pioglitazone, prediabetes, diabetes, obesity, Pancreatic fat