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CompletedNCT00522158Updated Aug 29, 2007

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

A Phase 4 interventional study of simvastatin and atorvastatin in Type 2 Diabetes Mellitus, Cardiovascular Disease and LDL Cholesterol, sponsored by Baskent University. Completed. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-08-29.

Sponsored by Baskent University · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Cardiovascular Disease
  • LDL Cholesterol
  • Cognition
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

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Lead sponsor

Baskent University is the lead sponsor of 201 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All

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

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
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • Drugsimvastatin
  • Drugatorvastatin
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00522158
Lead sponsor
Baskent University
First posted
Aug 29, 2007
Last update
Aug 29, 2007

Study contacts

Zehra Berberoglu, MD
principal investigator · Baskent University Faculty of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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