Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00522158
First received: August 27, 2007
Last updated: August 28, 2007
Last verified: August 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Baskent University:

  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

No publications provided

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Atorvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014