Cardiovascular Disease, Cognition, LDL Cholesterol, Type 2 Diabetes Mellitus
Conditions
Brief summary
We aimed to compare the effect of achieving an LDL-cholesterol \<70 vs an LDL-cholesterol \<100 mg/dL with simvastatin or atorvastatin on adrenal and testicular steroidogenesis, and cognition in diabetic patients.
Interventions
DRUGsimvastatin
DRUGatorvastatin
Sponsors
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Inclusion criteria
* patients with controlled type 2 diabetes mellitus with overt CVD * patients with controlled type 2 diabetes mellitus over the age of 40 years without overt CVD,but with one or more major cardiovascular risk factors
Exclusion criteria
* uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>95 mm Hg); evidence of active active liver disease or hepatic dysfunction defined as a level of liver transaminases \>2 times the upper limit of normal; uncontrolled myocardial ischaemia; congestive heart failure (New York Heart Association classification IIIb or IV); hemodynamically important valvular disease; secondary hypercholesterolemia; gastrointestinal disease that might limit drug absorption or partial ileal bypass; myopathy, or rhabdomyolysis; a known hypersensitivity to statins; using any androgenic, estrogenic, progestogenic, antiandrogenic, or antiestrogenic agents or medications that can alter the gonadal steroid milieu; using systemic immunosuppressants or anticoagulants; plasma creatine kinase levels \>50% above the upper limit of normal,transient ischaemic attack or stroke in past,severe hypertriglyceridaemia (fasting triglyceride level ≥350 mg/dl,Currently on psychotropic medications, steroids, opiate analgesics, Known case of major neuropsychiatric illness,Poor cognition at baseline \[Mini-Mental State Examination(MMSE) score ≤24\],Physically or mentally unable to complete tests, history of other risk factors for hearing loss and/or conventional assessment that presented conductive hearing loss, confirmed by acoustic immittance measurement;presence of non-auditory associated disorders that could lead to long-latency potentials, such as neurological diseases or syndromes
Outcome results
None listed