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| ID | Type | Description | Link |
|---|---|---|---|
| A-13-001-UCD-SK-NH | Other Grant/Funding Number | California Dairy research Foundation |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM).
11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.
Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin response. Therefore insulin secretagogues are a significant component of the therapeutic armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. These medicines can also cause side effects, including hypoglycemia. Limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research which aims to identify an alternate insulin secretagogue is important and timely.
Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a potent insulin secretagogue. Although it is well known that protein and/or AA intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical insulin secretagogues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein group | Active Comparator | Patients will be randomized to receive whey protein |
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| Placebo group | Placebo Comparator | Patients will be randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Level | each day up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 hour urine C-peptide excretion level | baseline and 1 month up to 3 months | |
| Change in Weight | 1 month up to 3 months | |
| Change in Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sidika E Kasim-Karakas, M.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Science Center Clinical Resources Center (CCRC) | Sacramento | California | 95655 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| 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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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Placebo group | Dietary Supplement | Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months. |
|
| 1 month up to 3 months |
| Change in vital signs | 1 month up to 3 months |
| Change in DEXA | baseline and 1 month up to 3 months |
| Change in Free fatty acids (FFA) levels | baseline and 1 month up to 3 months |
| Change in Lipid levels | baseline and 1 month up to 3 months |
| Change in GLP-1 levels | baseline and 1 month up to 3 months |
| Change in hs-CRP levels | baseline and 1 month up to 3 months |
| Change in Glycated hemoglobin (HgBA1C) level | baseline and 1 month up to 3 months |
| Change in Urine glucose level | baseline and 1 month up to 3 months |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |