Status:
WITHDRAWN
Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Detailed Description
Cross sectional and population-based studies indicate that at least one third of all patients with congestive heart failure (CHF) have a normal or near normal ejection fraction, which is thought to be...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
- Patients who are placed in the control group may not be currently taking a medication in the glitazones drug class.
- Current or prior use of Pioglitazone or Rosiglitazone within the preceding 6 months.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00232362
Start Date
June 1 2007
End Date
June 1 2008
Last Update
April 13 2015
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