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Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for thousands of years in China. The glucose-lowering effect of BBR has been confirmed in numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts its effects are not yet fully elucidated. In previous data, Jin-Kui Yang found that BBR could promote insulin secretion in mice and isolated islets. In this current study, investigators plan to examine the insulinotropic effect of BBR in human through hyperglycemic clamp method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine treatment | Experimental |
| |
| Placebo control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine Chloride | Drug | Traditional Chinese Medicine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | To compare the mean serum insulin levels in the two groups during hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period |
| Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | To compare the mean serum C-peptide levels in the two groups during hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. | To compare the mean glucose infusion rates in the two groups during hyperglycemic clamp study. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate and QT-interval duration using electrocardiogram before and after drug treatment. | Electrocardiogram will be performed in subjects before and after drug treatment. | Single dosage for one experiment and crossover repeat once after 2 weeks washout period |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34556670 | Derived | Zhao MM, Lu J, Li S, Wang H, Cao X, Li Q, Shi TT, Matsunaga K, Chen C, Huang H, Izumi T, Yang JK. Berberine is an insulin secretagogue targeting the KCNH6 potassium channel. Nat Commun. 2021 Sep 23;12(1):5616. doi: 10.1038/s41467-021-25952-2. |
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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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| Placebo | Drug | Placebo Control |
|
| Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. |
To compare the mean blood glucose levels in the two groups during hyperglycemic clamp study. |
| Single dosage for one experiment and crossover repeat once after 2 weeks washout period |