dysglycemia
Conditions
Interventions
test group 1:Perfect Brand Mulberry Leaves and Hippophae Protein Peptid Solid Drink
control group:placebo
test group 2:Perfect Brand Mulberry Leaves and Hippophae Protein Peptid Solid Drink
Sponsors
Qingdao Center Hospital,University of Health and Rehabilitation Sciences.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 (inclusive), gender is not limited. 2.BMI between 24~32. 2.1 Normal blood glucose population (20 cases): people with fasting blood glucose <5.6 mmol/L. 2.2 Pre-diabetic population (60 cases): 2.2.1 People with impaired glucose regulation (IGR) who have a fasting blood glucose of 5.6-7.0 mmol/L or a 2-hour postprandial blood glucose of 7.8-11.1 mmol/L; 2.2.2 Never taken hypoglycemic drugs. 2.3 Type II diabetic population (40 cases): 2.3.1 Confirmed diagnosis of type 2 diabetes mellitus, taking oral metformin only for more than one month; 2.3.2 People with diabetes who have fasting blood glucose 7.0-9.0 mmol/L or 2-hour postprandial blood glucose 11.1-14.0 mmol/L with glycated hemoglobin 6.5%-8% while taking metformin only, with a daily dose of 500-1500 mg of metformin.
Exclusion criteria
Exclusion criteria: 1. Those who also suffer from diseases of the cardiovascular system, immune system, nervous system, digestive system, respiratory system, etc. that may affect the subjects' compliance with the test or the judgment of the validity and safety of this test, such as major liver diseases (e.g., viral liver disease), infectious diseases, and psychiatric patients; 2. History of major cardiovascular and cerebrovascular diseases within 3 months prior to screening, such as myocardial infarction and stroke; 3. Those who have taken items related to subject function (except metformin) for a short period of time, e.g., glucocorticoids, which affects the judgment of the results. 4. Glutaminotransferase and/or glutamate aminotransferase exceeding the normal range at screening in the normoglycemic group; glutaminotransferase and/or glutamate aminotransferase above 2 times ULN at screening in the remaining two groups; blood creatinine exceeding the normal range; urine protein: 1+ or more in the normoglycemic group and pre-diabetic group, and 2+ or more in diabetic patients. 5. People at high risk of serious diseases associated with hyperglycemia or those who have developed the disease, such as diabetic ketosis, acidosis, hyperosmolar coma, and severe infections in the last 3 months. 6. Pregnant or breastfeeding or planning to become pregnant during the trial; 7. Other reasons why the investigator considers participation in this study to be unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fasting blood sugar;2-hour postprandial blood glucose(OGTT);Insulin resistance index HOMA-IR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-hour postprandial glucose;glycosylated hemoglobin;Insulin 2 hours after meal;Fasting C-peptide;C-peptide 2 hours after meal;Clinical Symptoms Scorecard; | — |
Countries
China
Contacts
Public ContactZhou Xuefeng
Qingdao Center Hospital,University of Health and Rehabilitation Sciences.
Outcome results
None listed