Clinical trial: Efficacy Study of Metformin Glycinate on Postprandial Lipemia (NCT02064881)

Eligibility criteria:
Inclusion Criteria:

          -  Patients of both sexes

          -  Between 35 and 65 years old

          -  Patients with type 2 diabetes within two years of diagnosis according to the ADA
             criteria

          -  Overweight patients (BMI between 25.5 and 29.9 kg/m2) or with grade 1 obesity (BMI
             between 30.0 and 34.9 kg/m2), according to WHO classification

          -  Low HDL levels: <50 in women and <40 mg/dL in men

          -  Hypertriglyceridemia: >150 and less than 300 mg/dL

          -  Patients who had not taken antidiabetes drug treatment or with diet and exercise
             treatment, or with metformin or DPP4 inhibitor monotherapy

          -  HbA1c between 6.5 and 8.5%.

          -  Creatinine clearance >60 ml/min (calculated by Cockcroft and Gault)

          -  Informed consent form signed.

          -  Women using contraception.

        Exclusion Criteria:

          -  Patients with other types of diabetes (type 1, LADA, MODY, etc.).

          -  Patients with primary dyslipidemia.

          -  Patients with poorly substituted hypothyroidism TSH > 5 mU/mL.

          -  Patients hospitalized in the last month.

          -  Patients with a disease of poor short-term prognosis

          -  Patients with autoimmune or rheumatic diseases.

          -  Patients with acute infection or febrile illness.

          -  History of chronic liver disease or ALT or AST ≥ 2.0 times the upper limit of normal,
             or GGT ≥ 3 times the upper limit of normal.

          -  Patients with any other chronic disease, for example: HIV, rheumatic diseases.

          -  Pregnant or positive pregnancy test.

          -  Women who are breastfeeding.

          -  Patients in another research project.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 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? Contradiction