Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: pioglitazone
Intervention description: 45 mg per day for 6 months
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diastolic function; mitochondria; pioglitazone; pericardial fat

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.
    

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.