Type 2 Diabetes Mellitus, Heart Disease
Conditions
Interventions
80 subjects on monotherapy sulfanylurea for at least 10 weeks will be enrolled. Following, participants will be randomised to Metformin or Pioglitazone for 24 weeks.
Group 1: Metformin
Group 2: Pioglitazone
10 healthy subject will only undergo baseline measurements.
Sponsors
VU medical center
De Boelelaan 1117
1081 HV Amsterdam
The Netherlands
Eligibility
Inclusion criteria
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
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, I), atrial fibrillation or history of sustained ventricular tachycardia. Stroke within 6 months prior to enrollment. Microvascular complications, including: diabetic nephropathy, proliferative retinopathy, symptomatic macrovascular complications and/or (autonomic) neuropathy, except for background diabetic retinopathy. Leg ulcers, gangrene. Hyper sensibility to study medication. Current use of TZD/fibrates Healthy volunteersHistory or current cardiovascular diseaseDyslipidemia, requiring pharmacological treatment according to the Dutch Cholesterol Consensus 1998
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cardiac function and metabolism following treatment with PPARg agonist versus current state of the art therapy, metformin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose and FFA uptake by adipose tissue and skeletal muscle Cardiac high-energy-phosphate (HEP) metabolism. 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). | — |
Contacts
Public ContactL.J. Rijzewijk
VU University Medical Center, Department of Endocrinology, Diabetescenter, De Boelelaan 1117
Outcome results
None listed