NCT00522158CompletedPhase 4
Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Baskent University
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
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