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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232362
Recruitment Status : Withdrawn (This study was not conducted as the Principal Investigator left the institution)
First Posted : October 4, 2005
Last Update Posted : April 13, 2015
Information provided by:
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Pioglitazone (Actos) Drug: Anti-diabetic agent other than pioglitazone or rosiglitazone Phase 1

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 secondary to diastolic dysfunction or failure. The mortality rates among the patients with diastolic failure ranges from 5-8% annually, as compared with 10-15% among patients with systolic heart failure. The morbidity associated with diastolic heart failure is similar to that of systolic heart failure. Several studies have shown that even simple Doppler evidence of diastolic dysfunction is an independent risk factor for the development of CHF and cardiac death and increased all cause mortality. Several studies indicate that left ventricular diastolic dysfunction (LVDD) represent the earliest preclinical manifestation of diabetic cardiomyopathy that can progress to symptomatic heart failure. Recent studies have demonstrated up to 60% of asymptomatic, normotensive patients with type 2 diabetes have LVDD when assessed by conventional echocardiography including the response to the Valsalva maneuver. A recent study using conventional Doppler, valsalva maneuver, color M-mode echocardiography and tissue doppler imaging assessed the diastolic dysfunction in asymptomatic normotensive patients with diabetes mellitus and found diastolic dysfunction in about 75% of these patients. Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus. Although diabetic patients have a large number of cardiovascular risk factors, like hyperlipidemia and hypertension, the diabetic cardiomyopathy occurs independent of these risk factors. Recently animal models have shown that LVDD may be prevented by chronic treatment with peroxisome-proliferator-activated receptors gamma (PPAR) agonists, like thiazolidinediones, in type 2 diabetic rats. Thiazolidinediones act through PPAR, but the exact mechanism by which they improve LVDD is not known. With this background knowledge, we wanted to study the effect of Pioglitazone, which is PPAR agonist and partial PPAR agonist, on the left ventricular diastolic dysfunction in type 2 diabetic human subjects, which has not been studied so far. If this therapy proves to have beneficial effect on the LVDD it will help in preventing the deleterious consequences of diastolic dysfunction in diabetic patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
Study Start Date : June 2007
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio
  2. deceleration time (DT)
  3. isovolumic relaxation time (IVRT)
  4. E/A ratio percent change with Valsalva maneuver more than 40%
  5. annular tissue Doppler velocity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232362

Sponsors and Collaborators
Texas Tech University Health Sciences Center
Principal Investigator: Chanwit Roongsritong, MD TTUHSC Identifier: NCT00232362     History of Changes
Other Study ID Numbers: L05-115
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs