Suspended

Effects of Pioglitazone on Visceral Fat Metabolic Activity

What is being tested

Pioglitazone vs Glimepiride

+ Pioglitazone vs Glimepiride

Drug

Who is being recruted

From 35 to 58 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: March 2012

See protocol details

Summary

Principal SponsorKurume University

Study ContactNobuhiro Tahara, MD, PhDMore contacts

Last updated: March 27, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01819402

Principal SponsorKurume University

Study ContactNobuhiro Tahara, MD, PhDMore contacts

Last updated: March 27, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 58 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

Subjects between the ages of 35 and 85 years

Subjects with impaired glucose tolerance and type 2 diabetes

6 exclusion criteria prevent from participating

Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization

Subjects taking more than three antidiabetic medications

Subjects with cardiac failure (New York Heart Association Class > III) or left ventricular dysfunction (LVEF < 40%)

Subjects with insulin treatment

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

up to 30 mg pioglitazone, tablet, orally, once daily

Group II

Sham

up to 4 mg/day glimepiride, tablet, orally, once daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Kurume University

Kurume, JapanOpen Kurume University in Google Maps

SuspendedOne Study Center