[The efficacy and safety of recombinant human insulin injection in the treatment of diabetic patients:a multicenter, randomized, controlled and open-labeled clinical trial].

OBJECTIVE: A multicenter, randomized, controlled and open-labeled clinical trial was performed to compare the efficacy and safety of recombinant human insulin injection (Yousilin R) and Novolin R in diabetic patients. METHODS: A total of 211 cases were randomized into two groups (1:1) treated with Yousilin R versus Novolin R for 12 weeks respectively. RESULTS: Compared with baseline, the levels of glycosylated hemoglobin A1c (HbA1c) at the end of 12 weeks treatment decreased from 10.77% to 7.72%(P < 0.05) in Yousilin R group and from 10.33% to 7.62% (P < 0.05) in Novolin R group, 2-hour postprandial plasma glucose (2hPG) decreased from 15.49 mmol/L to 9.72 mmol/L (P < 0.05) in Yousilin R group and from 15.33 mmol/L to 10.07 mmol/L (P < 0.05) in Novolin R group, and fasting plasma glucose (FPG) decreased from 10.90 mmol/L to 7.31 mmol/L (P < 0.05) in Yousilin R group and from 10.22 mmol/L to 7.21 mmol/L (P < 0.05) in Novolin R group. The changes of HbA1c, 2hPG and FPG from baseline to endpoint in Yousilin R group was similar to those in Novolin R group (P > 0.05). Furthermore, hypoglycemic events (26.42% vs 30.48%), other adverse events (13.21% vs 16.19%), and serious adverse events (1.89% vs 1.90%) were comparable between Yousilin R and Novolin R groups (P > 0.05). CONCLUSIONS: Yousilin R has similar efficacy, safety and compliance profiles to Novolin R group in the treatment of diabetic patients.

Relationship between Trp64Arg mutation in the ß3-adrenergic receptor gene and metabolic syndrome: a seven-year follow-up study.

BACKGROUND: It has been shown that the ß3-adrenergic receptor (ß3-AR) gene Trp64Arg mutation was closely related to obesity and insulin resistance, and may be related to the prevalence of metabolic syndrome (MS). The aim of this study was to investigate the relationship between the ß3-AR gene mutation and the prevalence of MS. METHODS: A seven-year follow-up study was initiated in 2000, with 496 samples of simplex obese subjects (body mass index ≥ 25 kg/m(2)) and 248 normal-weight subjects. According to the ß3-AR genotypes, the subjects were classified as Trp64 homozygote group and Arg64 carrier group and after 7 years the prevalence of MS was determined. RESULTS: According to the baseline profile, there were no significant differences in the adiposity, blood pressure, lipid profile, fasting plasma glucose and fasting insulin between Trp64 homozygote group and Arg64 carrier group either in obesity or normal-weight subjects. The results of follow-up study indicated that in obese men the prevalence rate of MS was much higher in Arg64 carrier group than that in Trp64 homozygote group (54.76% vs. 40.85%, P < 0.05), but there was no statistical difference in women of the above groups. The prevalence rate of MS in obese men of both Trp64 homozygote group and Arg64 carrier obese group were obviously higher than that in women of the above groups (40.85% vs. 18.27% and 54.76% vs 21.28%, all P < 0.005). Differences were not statistically significant in the prevalence of MS for normal weight Trp64 homozygote group and normal weight Arg64 carrier group, either between men, between women, or between men and women. Comparison of populations indicated that no matter with the ß3-AR gene mutation or not, the prevalence of MS in obese subjects was significantly higher than normal weight subjects (χ(2) = 28.240 and χ(2) = 15.586, all P < 0.005). Logistic analysis showed that the mutation of ß3-AR gene was associated with the prevalence of MS in men. CONCLUSION: The mutation of ß3-AR gene is the independent risk factor for the prevalence of MS in men.

[A prospective study of the relationship between Trp64Arg beta(3)-adrenergic receptor gene polymorphism and metabolic syndrome].

OBJECTIVE: To investigate the relationship between Trp64Arg mutation in beta(3)-adrenergic receptor (beta(3)-AR) gene and the incidence of metabolic syndrome (MS). METHODS: A seven-year follow-up study was conducted in 386 simple obese subjects and 175 normal weight subjects in whom geno-typing of Trp64Arg mutation in beta(3)-AR gene was examined in 2000. RESULTS: There were no differences between a Trp64Trp homozygote group and a Trp64Arg heterozygote group of whether obese or normal weight subjects with respect to adiposity, blood pressure, lipid profile, fasting blood glucose and fasting insulin in the baseline. The results of follow-up indicated that the incidence of MS in the Trp64Arg heterozygote group was higher than that in the Trp64Trp homozygote group of obese males (54.76% vs 40.85%, P < 0.05) but not in the group of obese females. The incidences of MS both in the Trp64Trp homozygote group and Trp64Arg heterozygote group were higher in obese males than in obese females (40.85% vs 18.27% and 54.76% vs 21.28%, all P < 0.01). No significant differences were found in incidences of MS both in the Trp64Trp homozygote group and Trp64Arg heterozygote group of normal weight subjects whether the comparison was made between males and females respectively or between males and females. The overall incidence of MS in the obese subjects were significantly increased than that in the normal weight subjects whether there was gene variant or not (31.30% vs 6.03% and 42.75% vs 12.73%, all P < 0.01). Logistic analysis showed that beta(3)-AR gene variant was associated with increased incidence of MS in males. CONCLUSION: beta(3)-AR gene Trp64Arg mutation is an independent risk factor for the incidence of MS in males.