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Berberine (BBR) is the main active ingredient of the ancient Chinese herb medicine Coptis. The hypoglycemic effect of BBR has been demonstrated in numerous studies. Although BBR is safe and effective in the treatment of diabetes, its exact hypoglycemic mechanism is still unclear. Jin-Kui Yang found that BBR can promote GLP-1 secretion from intestinal L cells in mice in vitro and in vivo, thereby achieving the effect of lowering blood glucose, but it is still unknown whether BBR can promote incretin secretion in humans. In this study, investigators plan to examine the effect of BBR on secretion of incretin in human.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine Chloride | Experimental | This study employed a randomized, double-blind, placebo-controlled, two-period crossover design: subjects were randomized into two groups of equal size. The random allocation was conducted by asking volunteers to select the randomized number generated by computer. Each number represented placebo or BBR, and each group has the same number of numbers. The dosing sequence in the first group was oral BBR in the first cycle and oral placebo in the second cycle. The second group was administered placebo in the first cycle and BBR in the second cycle. Take the second dose 14 days after the first dose. After the last dose, continue to observe for 14 days to watch for side effects. On each experimental day, after an overnight fast, the subjects received a single oral dose of 1 g of BBR or a corresponding dose of the placebo. |
|
| Placebo control | Placebo Comparator | This study employed a randomized, double-blind, placebo-controlled, two-period crossover design: subjects were randomized into two groups of equal size. The random allocation was conducted by asking volunteers to select the randomized number generated by computer. Each number represented placebo or BBR, and each group has the same number of numbers. The dosing sequence in the first group was oral BBR in the first cycle and oral placebo in the second cycle. The second group was administered placebo in the first cycle and BBR in the second cycle. Take the second dose 14 days after the first dose. After the last dose, continue to observe for 14 days to watch for side effects. On each experimental day, after an overnight fast, the subjects received a single oral dose of 1 g of BBR or a corresponding dose of the placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine Chloride | Drug | Traditional Chinese medicine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of serum GLP-1 levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean serum GLP-1 in the two groups during glucose tolerance test. | 4 hours |
| Differences of serum GIP levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean serum GIP levels in the two groups during glucose tolerance test. | 4 hours |
| Differences of blood glucose levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean blood glucose levels in the two groups during glucose tolerance test. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of serum insulin levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean insulin levels in the two groups during glucose tolerance test. | The time frame is the same as Primary Outcome Measure 1 |
| Differences of serum C-peptide levels between BBR and placebo treatment groups during the glucose tolerance test. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of heart rate between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean heart rate in the two groups during glucose tolerance test. | 4 hours |
| Differences of QT-interval duration between BBR and placebo treatment groups during the glucose tolerance test. |
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 |
|---|---|---|---|
| 25498346 | Background | Lan J, Zhao Y, Dong F, Yan Z, Zheng W, Fan J, Sun G. Meta-analysis of the effect and safety of berberine in the treatment of type 2 diabetes mellitus, hyperlipemia and hypertension. J Ethnopharmacol. 2015 Feb 23;161:69-81. doi: 10.1016/j.jep.2014.09.049. Epub 2014 Dec 10. | |
| 26386988 | Background | Luthra A, Misra A. The marketing of unproven drugs for diabetes and dyslipidaemia in India. Lancet Diabetes Endocrinol. 2015 Oct;3(10):758-60. doi: 10.1016/S2213-8587(15)00328-9. No abstract available. |
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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 |
|
To compare the mean serum C-peptide levels in the two groups during glucose tolerance test. |
| 4 hours |
| Differences of serum potassium levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean serum potassium levels in the two groups during glucose tolerance test. | 4 hours |
| Differences of serum sodium levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean serum sodium levels in the two groups during glucose tolerance test. | 4 hours |
| Differences of serum chloride levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean serum chloride levels in the two groups during glucose tolerance test. | 4 hours |
| Differences of serum calcium levels between BBR and placebo treatment groups during the glucose tolerance test. | To compare the mean serum calcium levels in the two groups during glucose tolerance test. | 4 hours |
To compare the mean QT-interval duration in the two groups during glucose tolerance test. |
| 4 hours |
| Hao Wang |
| Beijing |
| China |