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Effects of Pioglitazone in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kazuhide Ogino, Tottori University Hospital
ClinicalTrials.gov Identifier:
NCT01472497
First received: July 21, 2011
Last updated: June 3, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Hypertension
Insulin Resistance
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone and Glimepiride in Hypertensive Patients - Relationship With AGE, Inflammatory Cytokines and Cardiac Markers -

Resource links provided by NLM:


Further study details as provided by Tottori University Hospital:

Primary Outcome Measures:
  • advanced glycation end-product (AGE) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • inflammatory cytokines (TNF-alfa, IL-6 and MCP-1) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • cardiac function (echo and BNP) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: April 2007
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glymepiride Drug: Pioglitazone
pioglitazone (15mg) once a day for 24 weeks
Other Name: actos

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension with insulin resistance

Exclusion Criteria:

  • Chronic systolic heart failure, ACS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472497

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

No publications provided

Responsible Party: Kazuhide Ogino, Associate Professor, Tottori University Hospital
ClinicalTrials.gov Identifier: NCT01472497     History of Changes
Other Study ID Numbers: PIO and HTN
Study First Received: July 21, 2011
Last Updated: June 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tottori University Hospital:
hypertension
insulin resistance
oral glucose tolerance test
AGE
inflammatory cytokine

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

ClinicalTrials.gov processed this record on November 20, 2014