Clinical trial: Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition (NCT00522158)

Eligibility 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
No condition on gender to be admitted to the trial.

Subject must be at least 40 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment