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Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588470
First Posted: May 1, 2012
Last Update Posted: December 6, 2017
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.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
  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: Intervention Model: Single Group Assignment
Intervention Model Description:

this study includes single arm intervention with pioglitazone. T2DM individuals will be studied at baseline and after 6 months treatment.

as a reference group, healthy subjects will be studied in cross sectional fashion. Because healthy subjects will not be treated nor restudied at 6 months, they can not be considered a separate arm in the study but rather a reference group

Masking: None (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 Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Change in E to A Ratio [ Time Frame: Baseline and 6-months Post Treatment ]
    The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.

  • Myocardial Glucose Uptake [ Time Frame: Baseline and 6-months Post Treatment ]
    Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone


Secondary Outcome Measures:
  • Change in Hemoglobin A1c [ Time Frame: Baseline and 6-months Post Treatment ]
    Change in hemoglobin A1c levels measured at 6 months


Enrollment: 130
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
Experimental: 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

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 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, pericardial fat content, and cardiac function.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ralph DeFronzo, Professor & Division Chief, Department of Medicine, Division of Diabetes, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588470     History of Changes
Other Study ID Numbers: MM20060280
T001 ( Other Grant/Funding Number: Takeda )
First Submitted: March 19, 2012
First Posted: May 1, 2012
Results First Submitted: February 17, 2016
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data will not be available for other researchers. However, a manuscript describing the study results is under review for publication in the medical literature

Keywords provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:
diastolic function
mitochondria
pioglitazone
pericardial fat

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