Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes

Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes

Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.

Inclusion Criteria:

• Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:

  (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;

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

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

• 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:

• Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.
• Subject that use exogenous insulin for glucose control.
• Subject that has a history of diabetic ketoacidosis.
• Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
• Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.
• Subject that has had operation less than six months prior to screening visit.
• Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.
• Subject is known to be allergic or intolerant to any ingredient found in the study product.