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| Name | Class |
|---|---|
| China Medical University, Taiwan | OTHER |
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The goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. It will also learn about the effects of bitter melon peptides on metabolic parameters. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bitter melon peptides | Experimental | Bitter melon peptide contains various active substances such as bitter melon saponins and bitter melon polysaccharides. |
|
| Placebo group | Placebo Comparator | The placebo capsule containing microcrystalline cellulose. The placebo is identical in appearance, color, and dosage schedule to the intervention product, but does not contain any active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bitter melon peptides | Dietary Supplement | Momordica charantia extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| glycemic variability | mean amplitude of glucose excursions and coefficient of variation, using CGM | From enrollment (day0) to day7 |
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control | Glycated hemoglobulin A1C | From enrollment (day0) to the end (day84) |
| Measure | Description | Time Frame |
|---|---|---|
| metabolic indicator | C-peptide | From enrollment (day0) to the end (day84) |
Inclusion Criteria:Participants were diagnosed with type 2 DM based on criteria recommended by the American Diabetes Association and required to have fasting plasma glucose of ≥126 mg/dl or an HbA1c of
≥ 6.5%, as measured on two separate occasions
Exclusion Criteria:cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PEI-YUNG LIAO, M.D. | Contact | +88647238595 | 48795@cch.org.tw |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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A total of 160 diabetic patients on Metformin monotherapy will be recruited and randomized into either the bitter melon peptide group or the placebo group for a 12-week clinical intervention
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