Clinical trial: Comparison of Nutritional Products for People With Type 2 Diabetes (NCT00797069)

Eligibility criteria:
Inclusion Criteria:

          1. Subject states that he/she has type 2 diabetes (as evidenced by use of oral
             hypoglycemic medication for at least two months).

          2. Subject is between 18 and 75 years of age, inclusive.

          3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
             prior to screening visit.

          4. If female is of childbearing potential, is practicing a method of birth control.

          5. Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.

          6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid
             medication or hormone therapy, subject has been on constant dosage for at least two
             months prior to screening visit.

        Exclusion Criteria:

          1. Subject uses exogenous insulin for glucose control.

          2. Subject states that he/she has type 1 diabetes.

          3. Subject states that he/she has a history of diabetic ketoacidosis.

          4. Subject takes an alpha-glucosidase inhibitor.

          5. Subject states that he/she has a current infection ; has had inpatient surgery, or
             corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior
             to screening visit.

          6. Subject states that he/she has an active malignancy (excluding the following dermal
             malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the
             cervix).

          7. Subject states that he/she has had a significant cardiovascular event ≤ six months
             prior to screening visit; or stated history of congestive heart failure.

          8. Subject states that he/she has end stage organ failure or is status post organ
             transplant.

          9. Subject states that he/she has a history of renal disease.

         10. Subject states that he/she has current hepatic disease.

         11. Subject states that he/she has a history of severe gastroparesis.

         12. Subject states that he/she has a chronic, contagious, infectious disease, such as
             active tuberculosis, Hepatitis B or C, or HIV.

         13. Subject has taken/is currently taking any herbals, dietary supplements, or
             medications, other than oral hypoglycemic medications, during the past four weeks
             prior to screening visit that could profoundly affect blood glucose.

         14. Subject states that he/she has clotting or bleeding disorders.

         15. Subject is known to be allergic or intolerant to any ingredient found in the study
             products.
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 75 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