Pioglitazone Influence of triglyceride Accumulation in the Myocardium in Diabetes.

Completed

Conditions: Type 2 Diabetes Mellitus, Heart Disease

Registration Number: NL-OMON21475

Lead Sponsor: VU medical centerDe Boelelaan 11171081 HV AmsterdamThe Netherlands

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Type 2 Diabetes PatientsMales, 45-65 years, DM2 (diagnosed according to WHO criteria, treated by monotherapy of sulfanylurea (i.e. unchanged during >30 days prior to inclusion).
At least three month stable HbA1c (<8.5%) under this therapy.
Sitting blood pressure <150/85 mmHg with or without antihypertensive drugs, BMI<32 kg/m2.Healthy volunteers, Healthy male subjects, 45-65 years, Normal sitting blood pressure <150/85 mmHg, BMI<32 kg/m2. Normal glucose tolerance as assessed by 75-g oral glucose tolerance test.

Exclusion Criteria

Type 2 Diabetes Patients, CAD, Active malignant disease, Impaired renal function (serum creatinine > 176 mmol/L), Weight >/= 45 kg (because of 11C-palmitate tracer), Anti-coagulant therapy, Severe
obstructive lung disease; hereditary lipoprotein disease, Impaired hepatic function (defined as ALT > 3 ULN) or a history of liver disease, Inability to understand study information, inability / unwillingness to sign informed consent, Substance abuse, Familial polyposis coli, <3 months after participation in other clinical trials.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in cardiac function and metabolism following treatment with PPARg agonist versus current state of the art therapy, metformin.

Secondary Outcome Measures

Name	Time	Method
Glucose and FFA uptake by adipose tissue and skeletal muscle Cardiac high-energy-phosphate (HEP) metabolism. <br />Hemodynamic and vascular parametersBody composition (body mass index (BMI), waist, adipose tissue distribution, including liver fat content, body fat percentage and fluid retention) Plasma parameters of glycemic control and lipoprotein metabolism Circulating levels of markers of inflammation, coagulation activation, fibrinolysis and endothelial functions Whole-body insulin sensitivity (by clamp).