Pioglitazone Decreases Visceral Fat Metabolism | NCT01819402

Studies
Pioglitazone Decreases Visceral Fat Metabolism

NCT01819402

Sponsor

Kurume University

Status

Unknown status

Last Update Posted

Mar 27, 2013Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging

Interventions

Pioglitazone vs Glimepiride

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 2013Estimated

Completion Date

Not provided

First Submitted Date

Mar 24, 2013

First Submission Date that Met QC Criteria

Mar 24, 2013

First Posted Date

Mar 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2013

Last Update Posted Date

Mar 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Comparator: 1	Active Comparator	up to 30 mg pioglitazone, tablet, orally, once daily	Drug: Pioglitazone vs Glimepiride
Sham Comparator: 1	Sham Comparator	up to 4 mg/day glimepiride, tablet, orally, once daily	Drug: Pioglitazone vs Glimepiride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pioglitazone vs Glimepiride	Drug		Active Comparator: 1 Sham Comparator: 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		Baseline and 16 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers		Baseline and 16 weeks after treatment

Other Outcomes

Measure	Description	Time Frame
All cardiovascular events and all cause death for 5 years		Baseline and 5 years after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects between the ages of 35 and 85 years
Subjects with impaired glucose tolerance and type 2 diabetes

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

58 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nobuhiro Tahara, MD, PhD	Contact	+81-942-31-7580		ntahara@med.kurume-u.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kurume University	Recruiting	Kurume		830-0011	Japan