地中海饮食预防糖尿病：一项随机试验的亚组分析。

Prevention of diabetes with Mediterranean diets: a subgroup analysis of a randomized trial.

出版信息

Ann Intern Med. 2014 Jan 7;160(1):1-10. doi: 10.7326/M13-1725.

Abstract

BACKGROUND

Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated.

OBJECTIVE

To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years).

DESIGN

Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639) SETTING: Primary care centers in Spain.

PARTICIPANTS

Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk.

INTERVENTION

Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included.

MEASUREMENTS

Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome).

RESULTS

During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet.

LIMITATIONS

Randomization was not stratified by diabetes status. Withdrawals were greater in the control group.

CONCLUSION

A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk.

PRIMARY FUNDING SOURCE

Instituto de Salud Carlos III.

摘要

背景

促进体重减轻的干预措施可以降低 2 型糖尿病的发病率。不限制热量的饮食改变是否也能预防糖尿病尚未得到评估。

目的

评估地中海饮食在 Prevención con Dieta Mediterránea 试验中的主要预防糖尿病的效果，该试验从 2003 年 10 月至 2010 年 12 月（中位随访时间为 4.1 年）。

设计

多中心随机试验的亚组分析。（当前对照试验：ISRCTN35739639）

地点

西班牙的基层医疗中心。

参与者

无糖尿病（3541 名年龄在 55 至 80 岁之间的高心血管风险患者）的男性和女性。

干预

参与者随机分组并按地点、性别和年龄分层，但不按糖尿病状态分组，接受以下 3 种饮食之一：富含特级初榨橄榄油的地中海饮食、富含混合坚果的地中海饮食或对照饮食（低脂饮食建议）。不包括增加体力活动或减肥的干预措施。

测量

新诊断 2 型糖尿病的发病率（预先指定的次要结局）。

结果

随访期间，富含特级初榨橄榄油的地中海饮食组、富含混合坚果的地中海饮食组和对照组分别发生 80、92 和 101 例新发糖尿病病例，相应的发病率分别为每 1000 人年 16.0、18.7 和 23.6 例。多变量调整后的危险比分别为富含特级初榨橄榄油的地中海饮食组 0.60（95%置信区间，0.43 至 0.85）和富含混合坚果的地中海饮食组 0.82（95%置信区间，0.61 至 1.10）与对照组相比。