Pioglitazone Decreases Visceral Fat Metabolism

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

Official title:

Effects of Pioglitazone on Visceral Fat Metabolic Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01819402
• Other study ID #: PIO FAT
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2013
• Last updated: March 24, 2013
• Start date: March 2012

Study information

• Verified date: March 2013
• Source: Kurume University
• Contact: Nobuhiro Tahara, MD, PhD
• Phone: +81-942-31-7580
• Email: ntahara[@]med.kurume-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 58 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pioglitazone vs Glimepiride

Locations

Country	Name	City	State
Japan	Kurume University	Kurume

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All cardiovascular events and all cause death for 5 years		Baseline and 5 years after treatment	Yes
Primary	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	Yes
Secondary	Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers		Baseline and 16 weeks after treatment	Yes