Effects of Pioglitazone in Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472497
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Kazuhide Ogino, Tottori University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Insulin Resistance Drug: Pioglitazone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone and Glimepiride in Hypertensive Patients - Relationship With AGE, Inflammatory Cytokines and Cardiac Markers -
Study Start Date : April 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: glymepiride Drug: Pioglitazone
pioglitazone (15mg) once a day for 24 weeks
Other Name: actos

Primary Outcome Measures :
  1. advanced glycation end-product (AGE) [ Time Frame: 24 weeks ]
  2. inflammatory cytokines (TNF-alfa, IL-6 and MCP-1) [ Time Frame: 24 weeks ]
  3. cardiac function (echo and BNP) [ Time Frame: 24 weeks ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypertension with insulin resistance

Exclusion Criteria:

  • Chronic systolic heart failure, ACS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472497

Tottori University Hospital
Yonago, Japan, 683-8504
Sponsors and Collaborators
Tottori University Hospital
Principal Investigator: Kazuhide Ogino, MD Tottori University Hospital

Responsible Party: Kazuhide Ogino, Associate Professor, Tottori University Hospital Identifier: NCT01472497     History of Changes
Other Study ID Numbers: PIO and HTN
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Kazuhide Ogino, Tottori University Hospital:
insulin resistance
oral glucose tolerance test
inflammatory cytokine

Additional relevant MeSH terms:
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs