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Pioglitazone on Pancreatic Steatosis and Bone Health

Effect of Pioglitazone on Pancreatic Steatosis and Bone Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00855010
Enrollment
42
Registered
2009-03-03
Start date
2009-02-28
Completion date
2013-12-31
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Keywords

Pioglitazone, prediabetes, diabetes, obesity, Pancreatic fat

Brief summary

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

Interventions

DRUGpioglitazone

pioglitazone 45 mg daily

DRUGplacebo

one daily

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pancreatic Fat Content12 monthsPancreatic 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)12 monthsIntact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
Bone Turnover Marker - Plasma 25-hydroxyvitamin D12 monthsPlasma 25-hydroxyvitamin D was determined by radioimmunoassay

Secondary

MeasureTime frameDescription
Visceral Fat Area12 monthsAbdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
Beta-cell Function12 monthsChanges in B-cell function as measured by acute insulin release to glucose (AIRg)
Disposition Index12 monthsDisposition 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
Bone Mineral Density12 monthsAreal 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.
Hepatic Fat Content12 monthsHepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Subcutaneous Fat Area12 monthsAbdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.

Countries

United States

Participant flow

Participants by arm

ArmCount
Pioglitazone
pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23
23
Placebo Pill
placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19
19
Total42

Baseline characteristics

CharacteristicPlacebo PillPioglitazoneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
18 Participants22 Participants40 Participants
Age, Continuous52.2 years
STANDARD_DEVIATION 10.6
52.6 years
STANDARD_DEVIATION 9.9
52.4 years
STANDARD_DEVIATION 10.3
Region of Enrollment
United States
19 Participants23 Participants42 Participants
Sex: Female, Male
Female
16 Participants11 Participants27 Participants
Sex: Female, Male
Male
3 Participants12 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 19
other
Total, other adverse events
7 / 236 / 19
serious
Total, serious adverse events
2 / 230 / 19

Outcome results

Primary

Bone Turnover Marker - Intact Parathyroid Hormone (PTH)

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

Time frame: 12 months

ArmMeasureValue (MEDIAN)
PioglitazoneBone Turnover Marker - Intact Parathyroid Hormone (PTH)41 pg/mL
Placebo PillBone Turnover Marker - Intact Parathyroid Hormone (PTH)56 pg/mL
Primary

Bone Turnover Marker - Plasma 25-hydroxyvitamin D

Plasma 25-hydroxyvitamin D was determined by radioimmunoassay

Time frame: 12 months

ArmMeasureValue (MEDIAN)
PioglitazoneBone Turnover Marker - Plasma 25-hydroxyvitamin D25 ng/mL
Placebo PillBone Turnover Marker - Plasma 25-hydroxyvitamin D19 ng/mL
Primary

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

ArmMeasureValue (MEDIAN)
PioglitazonePancreatic Fat Content9.6 Percentage of fat
Placebo PillPancreatic Fat Content13.0 Percentage of fat
Secondary

Beta-cell Function

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

Time frame: 12 months

ArmMeasureValue (MEDIAN)
PioglitazoneBeta-cell Function101 microUnits/mL x min
Placebo PillBeta-cell Function494 microUnits/mL x min
Secondary

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.

Time frame: 12 months

ArmMeasureGroupValue (MEAN)Dispersion
PioglitazoneBone Mineral DensityL2-L4 Lumbar spine BMD1.03 g/cm^2Standard Deviation 0.14
PioglitazoneBone Mineral DensityLeft femoral neck0.83 g/cm^2Standard Deviation 0.09
PioglitazoneBone Mineral DensityLeft total hip0.96 g/cm^2Standard Deviation 0.12
Placebo PillBone Mineral DensityL2-L4 Lumbar spine BMD1.03 g/cm^2Standard Deviation 0.14
Placebo PillBone Mineral DensityLeft femoral neck0.85 g/cm^2Standard Deviation 0.13
Placebo PillBone Mineral DensityLeft total hip1.02 g/cm^2Standard Deviation 0.12
Secondary

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

ArmMeasureValue (MEDIAN)
PioglitazoneDisposition Index410 Unitless
Placebo PillDisposition Index841 Unitless
Secondary

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

ArmMeasureValue (MEDIAN)
PioglitazoneHepatic Fat Content4.0 percentage
Placebo PillHepatic Fat Content5.8 percentage
Secondary

Subcutaneous Fat Area

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

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
PioglitazoneSubcutaneous Fat Area243 cm^2Standard Deviation 133
Placebo PillSubcutaneous Fat Area378 cm^2Standard Deviation 179
Secondary

Visceral Fat Area

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

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
PioglitazoneVisceral Fat Area302 cm^2Standard Deviation 88
Placebo PillVisceral Fat Area273 cm^2Standard Deviation 89

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026