Back to resultsEffects of Pioglitazone in Hypertensive Patients
Primary Purpose
Hypertension, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, insulin resistance, oral glucose tolerance test, AGE, inflammatory cytokine
Eligibility Criteria
Inclusion Criteria:
- Hypertension with insulin resistance
Exclusion Criteria:
- Chronic systolic heart failure, ACS
Sites / Locations
- Tottori University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
glymepiride
Arm Description
Outcomes
Primary Outcome Measures
advanced glycation end-product (AGE)
inflammatory cytokines (TNF-alfa, IL-6 and MCP-1)
cardiac function (echo and BNP)
Secondary Outcome Measures
Full Information
NCT ID
NCT01472497
First Posted
July 21, 2011
Last Updated
June 3, 2012
Sponsor
Tottori University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01472497
Brief Title
Effects of Pioglitazone in Hypertensive Patients
Official Title
Effects of Pioglitazone and Glimepiride in Hypertensive Patients - Relationship With AGE, Inflammatory Cytokines and Cardiac Markers -
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tottori University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Insulin Resistance
Keywords
hypertension, insulin resistance, oral glucose tolerance test, AGE, inflammatory cytokine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glymepiride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
actos
Intervention Description
pioglitazone (15mg) once a day for 24 weeks
Primary Outcome Measure Information:
Title
advanced glycation end-product (AGE)
Time Frame
24 weeks
Title
inflammatory cytokines (TNF-alfa, IL-6 and MCP-1)
Time Frame
24 weeks
Title
cardiac function (echo and BNP)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertension with insulin resistance
Exclusion Criteria:
Chronic systolic heart failure, ACS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuhide Ogino, MD
Organizational Affiliation
Tottori University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tottori University Hospital
City
Yonago
ZIP/Postal Code
683-8504
Country
Japan
12. IPD Sharing Statement
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Effects of Pioglitazone in Hypertensive Patients
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