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在 TODAY 临床试验中,治疗效果对身体成分测量指标的影响。

Treatment effects on measures of body composition in the TODAY clinical trial.

出版信息

Diabetes Care. 2013 Jun;36(6):1742-8. doi: 10.2337/dc12-2534.

Abstract

OBJECTIVE

The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) trial showed superiority of metformin plus rosiglitazone (M+R) over metformin alone (M), with metformin plus lifestyle (M+L) intermediate in maintaining glycemic control. We report here treatment effects on measures of body composition and their relationships to demographic and metabolic variables including glycemia.

RESEARCH DESIGN AND METHODS

Measures of adiposity (BMI, waist circumference, abdominal height, percent and absolute fat, and bone mineral content [BMC] and density [BMD]) were analyzed as change from baseline at 6 and 24 months.

RESULTS

Measures of fat accumulation were greatest in subjects treated with M+R and least in M+L. Although fat measures in M+L were less than those of M+R and M at 6 months, differences from M were no longer apparent at 24 months, whereas differences from M+R persisted at 24 months. The only body composition measure differing by race and/or ethnicity was waist circumference, greater in M+R than either M or M+L at both 6 and 24 months in whites. BMD and BMC increased in all groups, but increased less in M+R compared with the other two groups by 24 months. Measures of adiposity (increases in BMI, waist circumference, abdominal height, and fat) were associated with reduced insulin sensitivity and increased hemoglobin A1c (HbA1c), although effects of adiposity on HbA1c were less evident in those treated with M+R.

CONCLUSIONS

Despite differential effects on measures of adiposity (with M+R resulting in the most and M+L in the least fat accumulation), group differences generally were small and unrelated to treatment effects in sustaining glycemic control.

摘要

目的

青少年和青年 2 型糖尿病治疗选择(TODAY)试验表明,二甲双胍联合罗格列酮(M+R)优于二甲双胍单药治疗(M),而二甲双胍联合生活方式(M+L)在维持血糖控制方面则居中。我们在此报告治疗对身体成分测量值的影响及其与包括血糖在内的人口统计学和代谢变量的关系。

研究设计和方法

从基线开始,在 6 个月和 24 个月时分析肥胖指标(BMI、腰围、腹部高度、体脂百分比和绝对脂肪、骨矿物质含量 [BMC] 和密度 [BMD])的变化。

结果

在接受 M+R 治疗的患者中,脂肪堆积的指标最大,而在 M+L 治疗的患者中最小。尽管 M+L 治疗的脂肪指标在 6 个月时低于 M+R 和 M,但在 24 个月时不再与 M 有明显差异,而与 M+R 的差异则持续存在。仅有的一种按种族和/或民族划分的身体成分指标是腰围,在白人中,M+R 组在 6 个月和 24 个月时均大于 M 和 M+L 组。所有组的 BMD 和 BMC 均增加,但在 24 个月时,与其他两组相比,M+R 组的增加幅度较小。肥胖指标(BMI、腰围、腹部高度和脂肪的增加)与胰岛素敏感性降低和糖化血红蛋白 A1c(HbA1c)升高相关,但在接受 M+R 治疗的患者中,肥胖对 HbA1c 的影响则不那么明显。

结论

尽管在肥胖指标方面存在差异(M+R 导致脂肪堆积最多,M+L 导致脂肪堆积最少),但组间差异通常较小,与维持血糖控制的治疗效果无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0024/3661839/9aba65ee4ebd/1742fig1.jpg

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