Abstract

Background: Diabetes mellitus is one of the most common metabolic diseases in the world. Recently, willingness to use alternative treatments to control and reduce blood sugar levels has noticeably increased. The general objective of this study is to investigate the hypoglycemic effect of the active ingredient of Berberis (Berberine) in patients with type 2 diabetes. Methods: In this double-blind randomized controlled placebo trial, 84 patients with type 2 diabetes were evaluated. The patients were divided in 2 groups (42 each). In addition to their previous drugs, new diet, and life style each group received Berberine capsules 500 mg or placebo twice daily for 4 weeks. At baseline, weight, height, blood pressure, and BMI were calculated for all patients. Fasting plasma glucose, post- meal plasma glucose, fructosamine, lipid profile, fasting blood insulin levels, BUN, creatinine, and liver enzymes were taken from all patients before the study and after 4 weeks. HOMA-IR and HOMA-β% were calculated. Results: After administration of Berberine for a month, average blood sugar (FBS) in the Berberine group decreased from 192 ± 59.6 to 167.7 ± 51.8, which was statistically significant compared with the results of the placebo group (P = 0.036). There was a significant decrease from 266.1 ± 93.7 mg dl to 222.5 ± 76 in 2HPP in the Berberine group compared with the placebo group (P = 0.001). There was also a significant decrease from 425.7 ± 139.7 micromoles per liter to 344.9± 126.1 micromoles per liter in fructoseamine in the Berberine group compared with the placebo group (P = 0.014). In addition, fasting insulin, HOMA-β%, and HOMA-IR increased in the Berberine group compared with the placebo group, however, this increase was not statistically significant. There was a significant decrease in LDL, TG, VLDL in the Berberine group, however, it was not lower than that in the placebo group. Also, total cholesterol in the Berberine group decreased insignificantly compared to the placebo group. There was no significant difference between the 2 groups in terms of BMI, systolic, and diastolic blood pressure. Conclusions: The results showed taking Berberine in patients with type 2 diabetes for 1 month significantly reduces the fasting plasma glucose, post- meal blood glucose, and fructosamine. No signification changes were found in lipid profiles, fasting insulin, HOMA-IR, and HOMA-β%.

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