Clinical trial: Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients (NCT02274740)

Eligibility criteria:
Inclusion criteria:

        Male and female patients, 18-70 years of age.

        Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30
        kg/m^2) and the following other abnormalities:

          -  Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According
             to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).

          -  Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might
             reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual
             patients, if this can be achieved without significant hypoglycemia or other adverse
             effects of treatment. Appropriate patients might include those with short duration of
             diabetes, long life expectancy, and no significant cardiovascular disease).

          -  Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL,
             cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a
             primitive dyslipidemia).

          -  Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <40 mg/dL in men
             and <50 mg/dL in women).

        Written informed consent.

        Exclusion criteria:

        Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid
        suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of
        hypothyroidism).

        Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2
        times the upper limit of normal).

        Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of
        coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6
        months before enrollment.

        History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg
        and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic
        pancreatitis or of idiopathic acute pancreatitis.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Entailment