Clinical trial: Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics (NCT01324921)

Eligibility criteria:
Inclusion Criteria:

          1. type 2 diabetes

          2. between 21 and 75 years of age

          3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or
             postmenopausal or surgically sterile

          4. BMI is > 18.5 kg/m2 and <35 kg/m2

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

        Exclusion Criteria:

          1. Hemoglobin A1c value at screening of greater than or equal to 9%.

          2. Uses exogenous insulin or exenatide for glucose control.

          3. type 1 diabetes.

          4. history of diabetic ketoacidosis.

          5. 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. active malignancy

          7. significant cardiovascular event ≤ six months prior to screening visit; or stated
             history of congestive heart failure.

          8. end-stage organ failure or is status post organ transplant.

          9. history of renal disease.

         10. current hepatic disease.

         11. history of severe gastroparesis.

         12. chronic, contagious, infectious disease

         13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic
             medications, that could profoundly affect blood glucose.

         14. clotting or bleeding disorders

         15. allergic or intolerant to any ingredient found in the study products.

         16. habitual user of tobacco 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