To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT ImagingNCT01819402
Pioglitazone Decreases Visceral Fat Metabolism
A study testing Pioglitazone vs Glimepiride in people with To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging, run by Kurume University at 1 site in Japan.
Trial summary
Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. Read more about this study
- Who is it for?
- Ages 35 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging
- What is being tested?
- Pioglitazone vs Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects between the ages of 35 and 85 years
- Subjects with impaired glucose tolerance and type 2 diabetes
Who cannot join
- Subjects with insulin treatment
- Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease
- Subjects taking more than three antidiabetic medications
- Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization
- Subjects with cardiac failure (New York Heart Association Class > III) or left ventricular dysfunction (LVEF < 40%)
- Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kurume University
Kurume, 830-0011
Nobuhiro Tahara, MD, PhD, +81-942-31-7580, ntahara@med.kurume-u.ac.jp
About this study
Official title: Effects of Pioglitazone on Visceral Fat Metabolic Activity
Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.
- Being tested
- Pioglitazone vs Glimepiride
- Keywords
- visceral fat metabolism; FDG-PET/CT; pioglitazone; glimepiride; adiponectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone vs GlimepirideDrug
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: 1 | Active comparator | up to 30 mg pioglitazone, tablet, orally, once daily Receives: Drug: Pioglitazone vs Glimepiride |
| Sham Comparator: 1 | Sham comparator | up to 4 mg/day glimepiride, tablet, orally, once daily Receives: Drug: Pioglitazone vs Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging.
Measured: Baseline and 16 weeks after treatment
Secondary outcomes (1)
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers
Measured: Baseline and 16 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT ImagingStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuhiro Tahara, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819402
- Sponsor's protocol ID
- PIO FAT
- Status last verified
- Mar 2013
- First submitted
- 24 Mar 2013
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pioglitazone on Visceral Fat Metabolic Activity
- ClinicalTrials.gov ID
- NCT01819402
- Acronym / sponsor ID
- PIO FAT
- Keywords
- visceral fat metabolism; FDG-PET/CT; pioglitazone; glimepiride; adiponectin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (estimated)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: 1 | Active comparator | Drug: Pioglitazone vs Glimepirideup to 30 mg pioglitazone, tablet, orally, once daily |
| Sham Comparator: 1 | Sham comparator | Drug: Pioglitazone vs Glimepirideup to 4 mg/day glimepiride, tablet, orally, once daily |
Who may qualify
- Ages
- 35 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects between the ages of 35 and 85 years
- Subjects with impaired glucose tolerance and type 2 diabetes
Key exclusion criteria (6 listed)
- Subjects with insulin treatment
- Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease
- Subjects taking more than three antidiabetic medications
- Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization
- Subjects with cardiac failure (New York Heart Association Class > III) or left ventricular dysfunction (LVEF < 40%)
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 |
|---|---|---|
| Pioglitazone vs Glimepiride | Drug | Active Comparator: 1, Sham Comparator: 1 |
Primary outcome
Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging.
Time frame: Baseline and 16 weeks after treatment
1 secondary outcome
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers
Time frame: Baseline and 16 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
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.
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 vs Glimepiride in people with To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging, run by Kurume University at 1 site in Japan.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Mar 2013. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nobuhiro Tahara, MD, PhD (+81-942-31-7580, ntahara@med.kurume-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging. (time frame: Baseline and 16 weeks after treatment). 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 27 Mar 2013.