Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

NCT ID: NCT01588470

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Type 2 Diabetes; Coronary Heart Disease

Keywords

diastolic function; mitochondria; pioglitazone; pericardial fat

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pioglitazone

Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone

Group Type: EXPERIMENTAL

pioglitazone

Intervention Type: DRUG

45 mg per day for 6 months

Interventions

pioglitazone

45 mg per day for 6 months

Intervention Type: DRUG

Other Intervention Names

Actos

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Ralph DeFronzo

Professor & Division Chief, Department of Medicine, Division of Diabetes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph A DeFronzo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

References

Clarke GD, Solis-Herrera C, Molina-Wilkins M, Martinez S, Merovci A, Cersosimo E, Chilton RJ, Iozzo P, Gastaldelli A, Abdul-Ghani M, DeFronzo RA. Pioglitazone Improves Left Ventricular Diastolic Function in Subjects With Diabetes. Diabetes Care. 2017 Nov;40(11):1530-1536. doi: 10.2337/dc17-0078. Epub 2017 Aug 28.

Reference Type: DERIVED

PMID: 28847910 (View on PubMed)

Other Identifiers

T001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MM20060280

Identifier Type: -

Identifier Source: org_study_id