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NCT01472497 Clinical Trial

Effects of Pioglitazone in Hypertensive Patients

Hypertension Clinical Trial

Official title:
Effects of Pioglitazone and Glimepiride in Hypertensive Patients - Relationship With AGE, Inflammatory Cytokines and Cardiac Markers -

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01472497
Other study ID # PIO and HTN
Secondary ID
Status Completed
Phase Phase 4
First received July 21, 2011
Last updated June 3, 2012
Start date April 2007
Est. completion date March 2012

Study information
Verified date June 2012
Source Tottori University Hospital
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Insulin resistance is often complicated with hypertension. AGE and inflammation play important roles in insulin resistance. Some studies reported that pioglitazone, insulin sensitizer, is effective for patients with insulin resistance, however, the mechanisms are still unclear. The aim of this study to evaluate the effect of pioglitazone compared with glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in hypertensive patients during oral glucose tolerance test.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date March 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Hypertension with insulin resistance

Exclusion Criteria:

- Chronic systolic heart failure, ACS

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pioglitazone
pioglitazone (15mg) once a day for 24 weeks

Locations
Country Name City State
Japan Tottori University Hospital Yonago

Sponsors (1)
Lead Sponsor Collaborator
Tottori University Hospital

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary advanced glycation end-product (AGE) 24 weeks Yes
Primary inflammatory cytokines (TNF-alfa, IL-6 and MCP-1) 24 weeks Yes
Primary cardiac function (echo and BNP) 24 weeks Yes
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