糖尿病预防计划结局研究中强化生活方式和二甲双胍干预与虚弱的关联。
Association of Intensive Lifestyle and Metformin Interventions With Frailty in the Diabetes Prevention Program Outcomes Study.
机构信息
University of Texas Health Science Center at San Antonio.
Biostatistics Center, The George Washington University.
出版信息
J Gerontol A Biol Sci Med Sci. 2021 Apr 30;76(5):929-936. doi: 10.1093/gerona/glaa295.
BACKGROUND
Frailty is a geriatric syndrome of decreased physiologic reserve and resistance to stressors that results in increased vulnerability to adverse health outcomes with aging. Diabetes and hyperglycemia are established risk factors for frailty. We sought to examine whether the odds of frailty among individuals at high risk of diabetes randomized to treatment with intensive lifestyle (ILS), metformin, or placebo differed after long-term follow-up.
METHOD
The sample comprised participants in the Diabetes Prevention Program (DPP) clinical trial, who continued follow-up in the DPP Outcomes Study (DPPOS) and completed frailty assessments in DPPOS Years 8 (n = 2385) and 10 (n = 2289), approximately 12 and 14 years after DPP randomization. Frailty was classified using Fried Frailty Phenotype criteria. GEE models adjusting for visit year with repeated measures pooled for Years 8 and 10 were used to estimate pairwise odds ratios (ORs) between ILS, metformin, and placebo for the outcomes of frail and prefrail versus nonfrail.
RESULTS
Frailty prevalence by treatment group was ILS = 3.0%, metformin = 5.4%, placebo = 5.7% at Year 8, and ILS = 3.6%, metformin = 5.3%, placebo = 5.4% at Year 10. Odds ratios (95% CI) estimated with GEE models were ILS versus placebo, 0.62 (0.42-0.93), p = .022; metformin versus placebo, 0.99 (0.69-1.42), p = .976; and ILS versus metformin, 0.63 (0.42-0.94), p = .022. Odds of being frail versus nonfrail were 37% lower for ILS compared to metformin and placebo.
CONCLUSIONS
Early ILS intervention, at an average age of about 50 years, in persons at high risk of diabetes may reduce frailty prevalence in later life. Metformin may be ineffective in reducing frailty prevalence.
CLINICAL TRIALS REGISTRATION NUMBERS
NCT00004992 (DPP) and NCT00038727 (DPPOS).
背景
衰弱是一种与衰老相关的老年综合征，表现为生理储备和应激能力下降，导致对不良健康结果的易感性增加。糖尿病和高血糖是衰弱的既定危险因素。我们试图研究在长期随访后，随机接受强化生活方式（ILS）、二甲双胍或安慰剂治疗的高危糖尿病患者中，衰弱的可能性是否因个体而异。
方法
该样本包括糖尿病预防计划（DPP）临床试验的参与者，他们继续在 DPP 结局研究（DPPOS）中进行随访，并在 DPPOS 第 8 年（n=2385）和第 10 年（n=2289）完成衰弱评估，大约在 DPP 随机分组后 12 年和 14 年。使用 Fried 衰弱表型标准对衰弱进行分类。使用 GEE 模型调整每年的随访，并对第 8 年和第 10 年的数据进行汇总，以估计 ILS、二甲双胍和安慰剂治疗组在衰弱和衰弱前期与非衰弱组之间的两两比值比（OR）。
结果
根据治疗组，第 8 年时的衰弱发生率分别为 ILS=3.0%、二甲双胍=5.4%、安慰剂=5.7%，第 10 年时分别为 ILS=3.6%、二甲双胍=5.3%、安慰剂=5.4%。GEE 模型估计的比值比（95%CI）分别为 ILS 与安慰剂组，0.62（0.42-0.93），p=0.022；二甲双胍与安慰剂组，0.99（0.69-1.42），p=0.976；ILS 与二甲双胍组，0.63（0.42-0.94），p=0.022。与二甲双胍和安慰剂相比，ILS 治疗组的衰弱风险降低 37%。
结论
在高危糖尿病患者中，早期 ILS 干预（平均年龄约为 50 岁）可能会降低晚年衰弱的发生率。二甲双胍可能无法降低衰弱的发生率。
临床试验注册号
NCT00004992（DPP）和 NCT00038727（DPPOS）。
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