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Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition
This study has been completed.
Sponsored by: Baskent University
Information provided by: Baskent University
ClinicalTrials.gov Identifier: NCT00522158
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Disease
LDL Cholesterol
Cognition
Drug: simvastatin
Drug: atorvastatin
Phase IV

MedlinePlus related topics: Cholesterol Diabetes
Drug Information available for: Atorvastatin Atorvastatin calcium Simvastatin Cholest-5-en-3-ol (3beta)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522158

Sponsors and Collaborators
Baskent University
Investigators
Principal Investigator: Zehra Berberoglu, MD Baskent University Faculty of Medicine
  More Information

Study ID Numbers: KA 05/75
Study First Received: August 27, 2007
Last Updated: August 28, 2007
ClinicalTrials.gov Identifier: NCT00522158  
Health Authority: Turkey: Ethics Committee

Study placed in the following topic categories:
Metabolic Diseases
Simvastatin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Atorvastatin

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009