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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Cardiovascular Disease LDL Cholesterol Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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simvastatin

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Zehra Berberoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Baskent University Faculty of Medicine

Other Identifiers

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KA 05/75

Identifier Type: -

Identifier Source: org_study_id