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Completed

NCT Number: NCT00855010

Pioglitazone on Pancreatic Steatosis and Bone Health

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

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Type 2 Diabetes

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

pioglitazone 45 mg daily

Other names: Actos

Placebo

Drug

one daily

Other names: Placebo tablet resembling pioglitazone 45 mg.

Primary outcomes

  1. 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.

  2. Bone Turnover Marker - Intact Parathyroid Hormone (PTH)

    Time frame: 12 months

    Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .

  3. Bone Turnover Marker - Plasma 25-hydroxyvitamin D

    Time frame: 12 months

    Plasma 25-hydroxyvitamin D was determined by radioimmunoassay

Secondary outcomes

  1. Beta-cell Function

    Time frame: 12 months

    Changes in B-cell function as measured by acute insulin release to glucose (AIRg)

  2. 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.

  3. Subcutaneous Fat Area

    Time frame: 12 months

    Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.

  4. Visceral Fat Area

    Time frame: 12 months

    Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2009
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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