Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: LEHEL multi-nutrients supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEHEL multi-nutrients supplement<br>75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin. | Dietary Supplement: LEHEL multi-nutrients supplement<br>* The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.<br>|
| No Intervention: Control<br>Received only oral hypoglycemic agents. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control | Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention | Twelve weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition; Metabolic disorders