Clinical trial: Meal Timing on Postprandial Glucose, Insulin and GLP-1 in Type 2 Diabetes (NCT01977833)

Eligibility criteria:
Inclusion Criteria:

          1. Type 2 diabetes patients

          2. HbA1C > 7%

          3. Duration of diabetes: 0.5 to 10 years

          4. Subjects ≥ 30 and ≤70 years of age

          5. BMI: 22 to 35 kg/m2

          6. Diet controlled diabetic. Only treatment with metformin will be allowed

          7. Normal liver and kidney function

          8. Normal thyroid function

          9. Acceptable health beside diabetes based on interview, medical history, physical
             examination, and laboratory tests

         10. Stable physical activity pattern during the three months immediately preceding study

         11. Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.

         12. No shift work within 5 years of the study

         13. Did not cross time zones within 1 month of the study

         14. Read and understood the informed consent form and signed it voluntarily

        Exclusion Criteria:

          1. Type 1 diabetes

          2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric,
             infectious, malignant disease

          3. Abnormal liver function tests defined as an increase by a factor of at least 2 above
             the upper normal limit of alanine aminotransferase (ALT) and/or aspartate
             aminotransferase (AST)

          4. Pregnancy or lactation

          5. Illicit drug abuse or alcoholism

          6. Treatment with antidiabetic drugs, insulin or GLP-1 analogs

          7. Subjects taking anoretic drugs during the month immediately prior to study

          8. Subjects on steroid treatment

          9. Those with eating disorders

         10. Subjects after bariatric surgery, will be excluded
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 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? Contradiction