NCT00232362

Brief Summary

This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Typical duration for phase_1 type-2-diabetes-mellitus

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

First QC Date

September 30, 2005

Last Update Submit

April 9, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

  • Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio

  • deceleration time (DT)

  • isovolumic relaxation time (IVRT)

  • E/A ratio percent change with Valsalva maneuver more than 40%

  • annular tissue Doppler velocity

Interventions

Pioglitazone (Actos)DRUG
Anti-diabetic agent other than pioglitazone or rosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes mellitus (DM)
  • Ages 18 to 65 years old
  • Patients with left ventricular diastolic dysfunction (LVDD) and ejection fraction (EF) \> 50%

You may not qualify if:

  • Patients with uncontrolled hypertension
  • Patients with active myocardial ischemia with Canadian Cardiovascular Society (CCS) \> II or known coronary artery disease (CAD)
  • Patients with atrial fibrillation
  • Patients with systolic heart failure
  • Patients with mitral regurgitation grade 2 or more
  • Patients with restrictive cardiomyopathy
  • Patients with constrictive pericarditis
  • Pregnant female patients
  • Recent stroke
  • Sepsis
  • Liver enzymes more than 2.5 times the normal
  • Hemoglobin \< 11g/dl or hematocrit \< 30%
  • Terminal cancer
  • Patients on fibrates group of lipid lowering agents
  • Patients already on pioglitazone or rosiglitazone
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PioglitazoneRosiglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chanwit Roongsritong, MD

    TTUHSC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

June 1, 2007

Study Completion

June 1, 2008

Last Updated

April 13, 2015

Record last verified: 2015-04