NCT01472497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

4.7 years

First QC Date

July 21, 2011

Last Update Submit

June 3, 2012

Conditions

HypertensionInsulin Resistance

Keywords

hypertensioninsulin resistanceoral glucose tolerance testAGEinflammatory cytokine

Outcome Measures

Primary Outcomes (3)

  • advanced glycation end-product (AGE)

    24 weeks

  • inflammatory cytokines (TNF-alfa, IL-6 and MCP-1)

    24 weeks

  • cardiac function (echo and BNP)

    24 weeks

Study Arms (1)

glymepiride

EXPERIMENTAL
Drug: Pioglitazone

Interventions

PioglitazoneDRUG

pioglitazone (15mg) once a day for 24 weeks

Also known as: actos
glymepiride

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension with insulin resistance

You may not qualify if:

  • Chronic systolic heart failure, ACS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tottori University Hospital

Yonago, 683-8504, Japan

Location

MeSH Terms

Conditions

HypertensionInsulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kazuhide Ogino, MD

    Tottori University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2011

First Posted

November 16, 2011

Study Start

April 1, 2007

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

JP(1)