National Institute of Endocrinology, Havana, Cuba.
J Diabetes. 2013 Jun;5(2):180-91. doi: 10.1111/1753-0407.12007.
The aim of the present study was to determine whether the administration of Diamel, marketed as a food supplement by Catalysis Laboratories (Madrid, Spain) could improve any of the components of metabolic syndrome (MS), as well as insulin resistance and sensitivity.
In all, 100 patients with MS (19-70 years of age) who satisfied the World Health Organization criteria for MS were included in the study. Participants were randomly assigned to receive either oral Diamel or a placebo (while maintaining a diet appropriate to their weight and physical activity) at a dose of two capsules before each of the three main meals each day for 1 year. Anthropometric indices, blood pressure, fasting plasma glucose, lipid profile, insulin, creatinine, and uric acid (UA) were determined. Insulin resistance (IR) was assessed and three indirect indices were used to calculate insulin sensitivity (IS).
Compared with placebo, Diamel improved fasting insulin concentrations, IS, and IR and reduced UA concentrations from 6 months until the end of treatment (P < 0.05 for all). In addition, after 12 months treatment with Diamel, significant changes from baseline were seen for mean fasting insulin (P < 0.05), UA (P < 0.05), IR (P < 0.001), and IS (P < 0.001), whereas no such changes were seen in the placebo-treated group. Improvements were noted in body mass index, IR, and IS in both groups.
Long-term Diamel treatment, combined with lifestyle changes, was beneficial for IR and IS, and reduced serum UA levels in patients with MS.
本研究旨在确定 Diamel（由 Catalysis Laboratories（西班牙马德里）作为膳食补充剂销售）的给药是否可以改善代谢综合征（MS）的任何组成部分，以及胰岛素抵抗和敏感性。
共有 100 名符合世界卫生组织 MS 标准的 MS 患者（19-70 岁）纳入本研究。参与者被随机分配接受口服 Diamel 或安慰剂（同时保持适合其体重和体力活动的饮食），剂量为每天三餐前各两粒，持续 1 年。测定体重指数、血压、空腹血糖、血脂谱、胰岛素、肌酐和尿酸（UA）。评估胰岛素抵抗（IR），并使用三个间接指标计算胰岛素敏感性（IS）。
与安慰剂相比，Diamel 改善了空腹胰岛素浓度、IS 和 IR，并从 6 个月开始一直降低至治疗结束时的 UA 浓度（所有 P < 0.05）。此外，Diamel 治疗 12 个月后，空腹胰岛素（P < 0.05）、UA（P < 0.05）、IR（P < 0.001）和 IS（P < 0.001）的平均水平均较基线显著变化，而安慰剂组则没有这种变化。两组的体重指数、IR 和 IS 均有改善。
长期 Diamel 治疗与生活方式改变相结合，对 MS 患者的 IR 和 IS 有益，并降低了血清 UA 水平。
