ObesityNCT00855010
Pioglitazone on Pancreatic Steatosis and Bone Health
A study testing pioglitazone in people with Obesity and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fat level in the pancreas above 4% (measurement done by us with an MRI)
- English speaker
- over 21 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 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.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- pioglitazone, placebo
- Keywords
- Pioglitazone, prediabetes, diabetes, obesity, Pancreatic fat
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Also called Actos
pioglitazone 45 mg daily
placeboDrug
Also called Placebo tablet resembling pioglitazone 45 mg.
one daily
| Study group | Role | What they receive |
|---|---|---|
| pioglitazone | Experimental | pioglitazone tablet 45 mg once daily Receives: Drug: pioglitazone |
| placebo pill | Placebo comparator | placebo pill once daily (look-alike pill which contains no active ingredients) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic Fat Content
Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Measured: 12 months
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
Measured: 12 months
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
Measured: 12 months
Secondary outcomes (6)
Beta-cell Function
Changes in B-cell function as measured by acute insulin release to glucose (AIRg)
Measured: 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.
Measured: 12 months
Subcutaneous Fat Area
Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.
Measured: 12 months
Visceral Fat Area
Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ildiko Lingvay, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855010
- Sponsor's protocol ID
- 112008-047
- Other IDs
- 1K23RRO24470-01
- Status last verified
- Nov 2017
- First submitted
- 27 Feb 2009
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Pancreatic Steatosis and Bone Health
- ClinicalTrials.gov ID
- NCT00855010
- Acronym / sponsor ID
- 112008-047
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Pioglitazone, prediabetes, diabetes, obesity, Pancreatic fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pioglitazone | Experimental | Drug: pioglitazonepioglitazone tablet 45 mg once daily |
| placebo pill | Placebo comparator | Drug: placeboplacebo pill once daily (look-alike pill which contains no active ingredients) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fat level in the pancreas above 4% (measurement done by us with an MRI)
- English speaker
- over 21 years old
Key exclusion criteria (6 listed)
- contraindication to MRI
- anemia
- pregnancy or desire to conceive
- use of unapproved medications
- prior pancreatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazoneAlso: Actospioglitazone 45 mg daily | Drug | pioglitazone |
| placeboAlso: Placebo tablet resembling pioglitazone 45 mg.one daily | Drug | placebo pill |
Primary outcome
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
6 secondary outcomes
Beta-cell Function
Time frame: 12 months
Hepatic Fat Content
Time frame: 12 months
Subcutaneous Fat Area
Time frame: 12 months
Visceral Fat Area
Time frame: 12 months
Bone Mineral Density
Time frame: 12 months
Disposition Index
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pioglitazone in people with Obesity and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic Fat Content (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.