OBJECTIVE: To explore the efficacy and influencing factors of chromium picolinate (tianmaixiaoke tablet) in the treatment of newly diagnosed type 2 diabetes mellitus in China. METHODS: A total of 84 outpatients with newly diagnosed type 2 diabetes mellitus visiting 4 hospitals in Beijing were randomly divided into two equal groups: study group receiving tianmaixiaoke tablet 240 mg bid for 24 weeks (n = 42) and control group sitagliptin 100 mg qd for 24 weeks (n = 42). The levels of fasting plasma glucose (FPG), plasma glucose 2 h after meal (PG2 h) and glycated hemoglobin (HbA1c) were detected before and 24 weeks after treatment. The serum levels of chromium and insulin were detected. RESULTS: Study was completed in 76 patients. The serum level of chromium was significantly lower in the diabetes group than in the normal group at baseline ((56 ± 28) µg/L vs (112 ± 21) µg/L, P = 0.00). At 24 weeks after treatment, the levels of HbA1c, FPG and PG2 h decreased while the serum level of chromium increased significantly in both groups. There were 11 patients with changed HbA1c from baseline (ΔHbA1c) ≥ 1% in the study group. At 24 weeks after treatment, HbA1c decreased by 1.61% (from 8.38% ± 0.72% to 6.77% ± 0.62%) and serum level of chromium increased by 35.14 µg/L in the ΔHbA1c ≥ 1% group with a low baseline serum level of chromium ((36.2 ± 18.0) µg/L). Both study group and control group were divided into three subgroups according to baseline serum level of chromium. ΔHbA1c reduced with the increase in baseline serum level of chromium in study group, while in control group, ΔHbA1c was unrelated with baseline serum level of chromium. At 24 weeks after treatment, insulin resistance index (HOMA-IR) reduced, β cell function index (HOMA-β) and insulinogenic index (IGI) increased in both groups. Multiple linear regression showed that the variables significantly associated with ΔHbA1c were baseline HbA1c and the baseline serum level of chromium. CONCLUSIONS:Chromium is commonly deficient in the newly diagnosed type 2 diabetics in China. HbA1c decreases and serum chromium increases significantly after chromium supplementation in the patients with a low baseline serum level of chromium.
RCT Entities:
OBJECTIVE: To explore the efficacy and influencing factors of chromium picolinate (tianmaixiaoke tablet) in the treatment of newly diagnosed type 2 diabetes mellitus in China. METHODS: A total of 84 outpatients with newly diagnosed type 2 diabetes mellitus visiting 4 hospitals in Beijing were randomly divided into two equal groups: study group receiving tianmaixiaoke tablet 240 mg bid for 24 weeks (n = 42) and control group sitagliptin 100 mg qd for 24 weeks (n = 42). The levels of fasting plasma glucose (FPG), plasma glucose 2 h after meal (PG2 h) and glycated hemoglobin (HbA1c) were detected before and 24 weeks after treatment. The serum levels of chromium and insulin were detected. RESULTS: Study was completed in 76 patients. The serum level of chromium was significantly lower in the diabetes group than in the normal group at baseline ((56 ± 28) µg/L vs (112 ± 21) µg/L, P = 0.00). At 24 weeks after treatment, the levels of HbA1c, FPG and PG2 h decreased while the serum level of chromium increased significantly in both groups. There were 11 patients with changed HbA1c from baseline (ΔHbA1c) ≥ 1% in the study group. At 24 weeks after treatment, HbA1c decreased by 1.61% (from 8.38% ± 0.72% to 6.77% ± 0.62%) and serum level of chromium increased by 35.14 µg/L in the ΔHbA1c ≥ 1% group with a low baseline serum level of chromium ((36.2 ± 18.0) µg/L). Both study group and control group were divided into three subgroups according to baseline serum level of chromium. ΔHbA1c reduced with the increase in baseline serum level of chromium in study group, while in control group, ΔHbA1c was unrelated with baseline serum level of chromium. At 24 weeks after treatment, insulin resistance index (HOMA-IR) reduced, β cell function index (HOMA-β) and insulinogenic index (IGI) increased in both groups. Multiple linear regression showed that the variables significantly associated with ΔHbA1c were baseline HbA1c and the baseline serum level of chromium. CONCLUSIONS:Chromium is commonly deficient in the newly diagnosed type 2 diabetics in China. HbA1c decreases and serum chromium increases significantly after chromium supplementation in the patients with a low baseline serum level of chromium.