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CompletedNCT00855010Updated Dec 13, 2017Results posted

Pioglitazone on Pancreatic Steatosis and Bone Health

An interventional study of pioglitazone and placebo in Obesity and Type 2 Diabetes, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
21 Years to 99 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity
  • Type 2 Diabetes

Keywords

  • Pioglitazone
  • prediabetes
  • diabetes
  • obesity
  • Pancreatic fat
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    pioglitazone

    pioglitazone tablet 45 mg once daily

    Drug: pioglitazone

  • Placebo comparator
    placebo pill

    placebo pill once daily (look-alike pill which contains no active ingredients)

    Drug: placebo

Interventions

  • Drugpioglitazone

    pioglitazone 45 mg daily

    Also known as: Actos

  • Drugplacebo

    one daily

    Also known as: Placebo tablet resembling pioglitazone 45 mg.

06

What researchers measure

Primary outcomes

  1. 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

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

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

    Time frame: 12 months

  3. Bone Turnover Marker - Plasma 25-hydroxyvitamin D

    Plasma 25-hydroxyvitamin D was determined by radioimmunoassay

    Time frame: 12 months

Secondary outcomes

  1. Beta-cell Function

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

    Time frame: 12 months

  2. 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

  3. Subcutaneous Fat Area

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

    Time frame: 12 months

  4. Visceral Fat Area

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

    Time frame: 12 months

  5. 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

  6. 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

07

Results

Posted Dec 13, 2017

Participant flow

Participant flow — Overall Study
MilestonePioglitazonePlacebo Pill
Started2319
Completed1918
Not completed41

Outcome measures

PrimaryPancreatic 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
Reported as:
Median · Percentage of fat
Pancreatic Fat Content
Percentage of fatPioglitazonePlacebo Pill
Pancreatic Fat Content9.6 (5.1 to 16.6)13.0 (6.1 to 20.2)
PrimaryBone Turnover Marker - Intact Parathyroid Hormone (PTH)

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

Time frame:
12 months
Reported as:
Median · pg/mL
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)
pg/mLPioglitazone:Placebo Pill:
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)41 (38 to 57)56 (51 to 74)
PrimaryBone Turnover Marker - Plasma 25-hydroxyvitamin D

Plasma 25-hydroxyvitamin D was determined by radioimmunoassay

Time frame:
12 months
Reported as:
Median · ng/mL
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
ng/mLPioglitazonePlacebo Pill
Bone Turnover Marker - Plasma 25-hydroxyvitamin D25 (15 to 30)19 (14 to 25)
SecondaryBeta-cell Function

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

Time frame:
12 months
Reported as:
Median · microUnits/mL x min
Beta-cell Function
microUnits/mL x minPioglitazonePlacebo Pill
Beta-cell Function101 (40 to 352)494 (264 to 748)
SecondaryHepatic 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
Reported as:
Median · percentage
Hepatic Fat Content
percentagePioglitazonePlacebo Pill
Hepatic Fat Content4.0 (1.7 to 10.9)5.8 (3.6 to 16.0)
SecondarySubcutaneous Fat Area

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

Time frame:
12 months
Reported as:
Mean · cm^2
Subcutaneous Fat Area
cm^2PioglitazonePlacebo Pill
Subcutaneous Fat Area243 ± 133378 ± 179
SecondaryVisceral Fat Area

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

Time frame:
12 months
Reported as:
Mean · cm^2
Visceral Fat Area
cm^2PioglitazonePlacebo Pill
Visceral Fat Area302 ± 88273 ± 89
SecondaryBone 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
Reported as:
Mean · g/cm^2
Bone Mineral Density
g/cm^2PioglitazonePlacebo Pill
L2-L4 Lumbar spine BMD1.03 ± 0.141.03 ± 0.14
Left femoral neck0.83 ± 0.090.85 ± 0.13
Left total hip0.96 ± 0.121.02 ± 0.12
SecondaryDisposition 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
Reported as:
Median · Unitless
Disposition Index
UnitlessPioglitazone:Placebo Pill:
Disposition Index410 (118 to 1458)841 (487 to 1491)

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pioglitazone0/23 (0%)2/23 (8.7%)7/23 (30.4%)
Placebo Pill0/19 (0%)0/19 (0%)6/19 (31.6%)
Most frequent serious events
Most frequent serious events
EventPioglitazonePlacebo Pill
Bacteremia with Streptococcus pneumoniaeInfections and infestations1/230/19
Motor vehicle traumaSurgical and medical procedures1/230/19
Right ankle traumaSurgical and medical procedures1/230/19
Most frequent other events
Most frequent other events
EventPioglitazonePlacebo Pill
TraumaGeneral disorders2/233/19
Fingers edemaGeneral disorders2/231/19
Lose consciousnessGeneral disorders0/231/19
MenorrhagiaReproductive system and breast disorders0/231/19
Urinary tract infectionRenal and urinary disorders0/231/19
FatigueHepatobiliary disorders1/230/19
HeadacheGeneral disorders1/230/19
Muscle crampsMusculoskeletal and connective tissue disorders1/230/19
LipomaMusculoskeletal and connective tissue disorders1/230/19
Shoulder arthroplastyMusculoskeletal and connective tissue disorders1/230/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PioglitazonePlacebo PillTotal
<=18 years000
Between 18 and 65 years221840
>=65 years112
Age, Continuous
Age, Continuous(years)PioglitazonePlacebo PillTotal
Mean52.6 ± 9.952.2 ± 10.652.4 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)PioglitazonePlacebo PillTotal
Female111627
Male12315
Region of Enrollment
Region of Enrollment(Participants)PioglitazonePlacebo PillTotal
United States231942
08

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00855010
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institutes of Health (NIH)
Responsible party
Ildiko Lingvay (MD, MPH, MSCS, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Mar 3, 2009
Start date
Feb 2009
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Dec 13, 2017
Last update
Dec 13, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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