二甲双胍或生活方式干预在糖尿病预防计划结果研究中的长期体重减轻效果。
Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study.
机构信息
Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana (J.W.A., K.M.G.).
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (E.M.V.).
出版信息
Ann Intern Med. 2019 May 21;170(10):682-690. doi: 10.7326/M18-1605. Epub 2019 Apr 23.
BACKGROUND
Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management.
OBJECTIVE
To identify some predictors of LTWL.
DESIGN
The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo. Its Outcomes Study (DPPOS) observed patients after the masked treatment phase ended. (ClinicalTrials.gov: NCT00004992 and NCT00038727).
SETTING
27 DPP and DPPOS clinics.
PARTICIPANTS
Of the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years.
MEASUREMENTS
Treatment assignment, personal characteristics, and weight.
RESULTS
After 1 year, 289 (28.5%) participants in the metformin group, 640 (62.6%) in the ILS group, and 137 (13.4%) in the placebo group had lost at least 5% of their weight. After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group. Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group.
LIMITATION
Post hoc analysis; examination of nonrandomized subsets of randomized groups after year 1.
CONCLUSION
Among persons with weight loss of at least 5% after 1 year, those originally randomly assigned to metformin had the greatest loss during years 6 to 15. Older age and the amount of weight initially lost were the most consistent predictors of LTWL maintenance.
PRIMARY FUNDING SOURCE
National Institutes of Health.
背景
确定长期减重（LTWL）的可靠预测因素可能会改善体重管理。
目的
确定 LTWL 的一些预测因素。
设计
DPP（糖尿病预防计划）是一项随机对照试验，比较了减重与二甲双胍、强化生活方式干预（ILS）或安慰剂的效果。其结局研究（DPPOS）在掩蔽治疗阶段结束后观察患者。（ClinicalTrials.gov：NCT00004992 和 NCT00038727）。
地点
27 个 DPP 和 DPPOS 诊所。
参与者
在 3234 名随机分配的参与者中，有 1066 名在第一年至少减轻了基线体重的 5%，并随访了 15 年。
测量
治疗分配、个人特征和体重。
结果
在第一年，二甲双胍组有 289 名（28.5%）、ILS 组有 640 名（62.6%）和安慰剂组有 137 名（13.4%）参与者至少减轻了 5%的体重。掩蔽治疗阶段结束后，与基线相比，在第 6 年至第 15 年期间保持的平均体重减轻量，二甲双胍组为 6.2%（95%CI，5.2%至 7.2%），ILS 组为 3.7%（CI，3.1%至 4.4%），安慰剂组为 2.8%（CI，1.3%至 4.4%）。LTWL 的独立预测因素包括所有组中第一年更大的体重减轻量、二甲双胍组中年龄更大和持续使用二甲双胍、ILS 组中年龄更大和没有糖尿病或糖尿病家族史以及安慰剂组中基线时更高的空腹血糖水平。
局限性
事后分析；第 1 年后对随机分组的非随机子集进行检查。
结论
在第 1 年至少减轻 5%体重的人群中，最初随机分配到二甲双胍组的人在第 6 年至第 15 年期间体重减轻最多。年龄较大和最初体重减轻量是 LTWL 维持的最一致预测因素。
主要资金来源
美国国立卫生研究院。
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