Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01588470
First received: March 19, 2012
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to examine the existence of heart abnormalities in patients with diabetes and the effect of pioglitazone in correcting these abnormalities.


Condition Intervention Phase
Type 2 Diabetes
Coronary Heart Disease
Drug: pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM) - Role of Intramyocellular Lipid Content and Mitochondrial Dysfunction in Myocardial Insulin Resistance and Their Correction With Pioglitazone

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • improvement in diastolic function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decrease myocardial fat content and improved mitochondrial function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone
Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone
Drug: pioglitazone
45 mg per day for 6 months
Other Name: Actos
No Intervention: No intervention

Detailed Description:

PRIMARY OBJECTIVES

  1. To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.
  2. To quantitate intramyocellular and pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects.
  3. To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects.
  4. To examine the effect of pioglitazone on myocardial insulin sensitivity, intramyocardial/pericardial fat content, and cardiac function.

SECONDARY OBJECTIVES To examine the relationships between myocardial insulin sensitivity, myocardial and pericardial fat content, and cardiac function before and after pioglitazone treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  • Patients may be of either sex. Female patients must be non-lactating and must either be at least one year post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period
  • Patients must range in age from 18 to 75 years, inclusive.
  • Patients with type 2 diabetes must be drug naïve, receiving monotherapy with metformin or with a sulfonylurea, or combination therapy with both: metformin & sulfonylurea.
  • Patients must have the following laboratory values:

    • Hematocrit ≥ 34 vol%
    • Serum creatinine ≤ 1.8 mg/dl
    • AST (SGOT) ≤ 2.5 times upper limit of normal
    • ALT (SGPT) ≤ 2.5 times upper limit of normal
    • Alkaline phosphatase ≤ 2 times upper limit of normal
  • Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
  • Only subjects whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

Exclusion Criteria:

  • Patients must not have type 1 diabetes.
  • Patients must not be receiving any medications with known adverse effects on glucose tolerance (except metformin or a sulfonylurea) unless the patient has been on stable doses of such agents for the past three months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy, if the patient has been on these agents for the prior three months. Patients taking systemic glucocorticoids are excluded.
  • Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
  • Patients with hematocrit < 34% will be excluded.
  • Patient who were exposed to any procedure involves radiation exposure and his total radiation dose equivalent exceeds 5 rem during the past year will be excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588470

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Ralph A DeFronzo, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588470     History of Changes
Other Study ID Numbers: MM20060280, T001
Study First Received: March 19, 2012
Last Updated: April 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
diastolic function
intramyocellular fat
mitochondria
pioglitazone

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014