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| ID | Type | Description | Link |
|---|---|---|---|
| 2012BAD33B10 | Other Identifier | National Key Technology Research and Development Program of China |
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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEHEL multi-nutrients supplement | Experimental | 75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin. |
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| Control | No Intervention | Received only oral hypoglycemic agents. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEHEL multi-nutrients supplement | Dietary Supplement | 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. |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Wenhua Ling, Ph.D. | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoguan University | Shaoguan | Guangdong | 512005 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044342 | Malnutrition |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D009748 | Nutrition Disorders |