Clinical trial: Cross-over Study on Effect of Lipid Lowering by Acipimox on Cardiac and Skeletal Muscle Mitochondrial Function (NCT00943059)

Eligibility criteria:
Inclusion Criteria:

          -  Male or postmenopausal females

          -  Age 40-70 years

          -  Obese (BMI > 30 kg/m2), non-insulin dependent type 2 diabetic patients and BMI matched
             control subjects without diabetes.

          -  Generally healthy with specifically no known cardiovascular disease, dyslipidemia, or
             gastric ulcers (contra-ind. of Acipimox), which can affect the study parameters.

          -  Must be on sulphonylurea(SU)- derivate or metformin therapy for at least six months
             with a constant dose for at least two months, or on dietary treatment for at least six
             months

          -  Well-controlled diabetes: HbA1c<8%.

          -  Control subjects must have a plasma glucose lower than 6,1 mmol/L.

          -  Stable dietary habits (no weight loss/gain > 3 kg in the last 6 months)

        Exclusion Criteria:

          -  Known cardiovascular disease, dyslipidemia, hepatic or renal failure and gastric
             ulcers.

          -  Insulin dependent Diabetic patients.

          -  Use of lipid lowering agents, except from Statins, as these do not affect
             triglycerides levels (with exception to Lipitor).

          -  Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone)

          -  Use of anti-coagulants (not thrombocyte-aggregation inhibitors)

          -  Aberrant ECG (with signs of ischemia or cardiac failure or arrythmia's)

          -  Weight gain/loss > 3 kg in the last 6 months.

          -  Hb < 7,3 in women, and < 7,8 in men.

          -  Contraindications for MRI scans:

               -  Electronic implants such as pacemakers or neurostimulator

               -  Iron-containing corpora aliena in eyes or brain

               -  Some hearing aids and artificial (heart) valves which are contraindicated for MRS

               -  Claustrophobia

          -  Subjects, who do not want to be informed about unexpected medical findings, or do not
             wish that their physician is informed, cannot participate in the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 70 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? 0