Effects of Pioglitazone in Hypertensive Patients

June 3, 2012 updated by: Kazuhide Ogino, Tottori University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Yonago, Japan, 683-8504
        • Tottori University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypertension with insulin resistance

Exclusion Criteria:

  • Chronic systolic heart failure, ACS

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: glymepiride
Drug: Pioglitazone
pioglitazone (15mg) once a day for 24 weeks
Other Names:
  • actos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
advanced glycation end-product (AGE)
Time Frame: 24 weeks
24 weeks
inflammatory cytokines (TNF-alfa, IL-6 and MCP-1)
Time Frame: 24 weeks
24 weeks
cardiac function (echo and BNP)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tottori University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 3, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIO and HTN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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