Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus

• Status: Withdrawn
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Treatments: Hypoglycemic Agents; Pioglitazone; Rosiglitazone

Criteria

Inclusion Criteria:

1. Patients with type 2 diabetes mellitus (DM)

2. Ages 18 to 65 years old

3. Patients with left ventricular diastolic dysfunction (LVDD) and ejection fraction (EF) > 50%

Exclusion Criteria:

1. Patients with uncontrolled hypertension

2. Patients with active myocardial ischemia with Canadian Cardiovascular Society (CCS) > II or known coronary artery disease (CAD)

3. Patients with atrial fibrillation

4. Patients with systolic heart failure

5. Patients with mitral regurgitation grade 2 or more

6. Patients with restrictive cardiomyopathy

7. Patients with constrictive pericarditis

8. Pregnant female patients

9. Recent stroke

10. Sepsis

11. Liver enzymes more than 2.5 times the normal

12. Hemoglobin < 11g/dl or hematocrit < 30%

13. Terminal cancer

14. Patients on fibrates group of lipid lowering agents

15. Patients already on pioglitazone or rosiglitazone

16. Patients who are placed in the control group may not be currently taking a medication in the glitazones drug class.

17. Current or prior use of Pioglitazone or Rosiglitazone within the preceding 6 months.