McDiarmid Sarah, Harvie Michelle, Johnson Rhona, Vyas Avni, Aglan Azza, Moran Jacqui, Ruane Helen, Hulme Amanda, Sellers Katharine, Issa Basil G
The Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.
Department of Endocrinology and Diabetes, Manchester University NHS Foundation Trust, Manchester, UK.
Diabetes Obes Metab. 2022 Mar;24(3):432-441. doi: 10.1111/dom.14592. Epub 2021 Dec 1.
To test the feasibility and potential efficacy of remotely supported intermittent low-energy diets (ILEDs) and continuous low-energy diets (CLEDs) in people with type 2 diabetes (T2D) and the feasibility of a randomized controlled trial comparing the two approaches.
Seventy-nine adults with overweight/obesity and T2D (≤8 years duration) were randomized 1:1 to CLED (8 weeks/56 days of daily Optifast 820 kcal (3430 kJ) diet) or isoenergetic ILED (2 days of Optifast and 5 days of a Mediterranean diet/week for 28 weeks). Weight maintenance/continued weight loss was undertaken for the remainder of the 52 weeks. Both groups received frequent telephone or the Oviva app support. Feasibility outcomes included study uptake, retention, app usage, dietary adherence, weight loss and change in glycated haemoglobin (HbA1c) at 52 weeks.
We enrolled 39 ILED and 40 CLED participants and 27 (69%) ILED and 30 CLED (75%) attended the 52-week follow-up. Eighty-nine per cent (70 of 79) started using the app and 86% (44 of 51) still used the app at 52 weeks. Intention-to-treat analysis at 52 weeks showed percentage weight loss was mean (95% confidence interval) -5.4% (-7.6, -3.1%) for ILED and -6.0% (-7.9, -4.0%) for CLED. HbA1c <48 mmol/mol was achieved in 42% of both groups. Mean (95% confidence interval) changes in the T2D medication effect score were 0.0008 (-0.3, 0.3) for ILED and -0.5 (-0.8, -0.3) for CLED.
The study shows the feasibility and potential efficacy of remotely delivered ILED and CLED programmes for weight loss and HbA1c reduction, and the feasibility of a randomized controlled trial comparing the two approaches.
测试远程支持的间歇性低能量饮食（ILED）和持续低能量饮食（CLED）对2型糖尿病（T2D）患者的可行性和潜在疗效，以及比较这两种方法的随机对照试验的可行性。
79名超重/肥胖且患有T2D（病程≤8年）的成年人按1:1随机分为CLED组（每日食用Optifast 820千卡（3430千焦）饮食，共8周/56天）或等能量ILED组（2天食用Optifast，每周5天食用地中海饮食，共28周）。在余下的52周进行体重维持/持续减重。两组均接受频繁的电话或Oviva应用程序支持。可行性结果包括研究纳入率、保留率、应用程序使用率、饮食依从性、52周时的体重减轻情况和糖化血红蛋白（HbA1c）变化。
我们招募了39名ILED参与者和40名CLED参与者，27名ILED参与者（69%）和30名CLED参与者（75%）参加了52周的随访。89%（79名中的70名）开始使用该应用程序，52周时86%（51名中的44名）仍在使用该应用程序。52周时的意向性分析显示，ILED组的体重减轻百分比平均为（95%置信区间）-5.4%（-7.6，-3.1%），CLED组为-6.0%（-7.9，-4.0%）。两组均有42%的患者HbA1c<48 mmol/mol。ILED组T2D药物疗效评分的平均（95%置信区间）变化为0.0008（-0.3，0.3），CLED组为-0.5（-0.8，-0.3）。
该研究表明远程提供的ILED和CLED方案在减重和降低HbA1c方面具有可行性和潜在疗效，以及比较这两种方法的随机对照试验的可行性。
