Hyperlipidemia in patients with diabetes seems associated with a thrombogenic plasma fibrin gel structure and impaired microvascular function. We hypothesize that lipid lowering with a statin leads to the formation of a more porous and less thrombogenic fibrin network in turn leading to improved microvascular function. This may contribute to the positive effect of statins on vascular complications.
Conditions
Interventions
Trade Name: Lipitor
Product Name: Lipitor
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Karolinska Institute Danderyd Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 1 diabetes mellitus and hyperlipidemia defined as total cholesterol>4.5 mmol/L and/or LDL-cholesterol >2.5 mmol/L. Age 30-60 years Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using contraceptive methods such as oral contraceptives, barrier method, or an intrauterine device. Written informed consent from the patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Intolerance to statins History of any macrovascular event, such as myocardial infarction, coronary revascularisation procedure, stroke, TIA, peripheral arterial occlusive disease Evidence of active inflammatory muscle disease Impaired hepatic function defined as ASAT/ALAT >1.4 ukat/L Nephropathy defined as S-creatinine >130 umol/L Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of two months treatment with atorvastatin on the structure of fibrin gel formed in plasma from individuals with type 1 diabetes mellitus and hyperlipidemia.;Secondary Objective: To investigate the effects of two months treatment with atorvastatin on the microvascular function, and various coagulation and inflammatory markers in individuals with type 1 diabetes mellitus and hyperlipidemia.;Primary end point(s): To investigate the effect of two months treatment with atorvastatin on the structure of fibrin gel formed in plasma from individuals with type 1 diabetes mellitus and hyperlipidemia. | — |
Countries
Sweden
Outcome results
None listed