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优化斋月禁食:一项在斋月期间针对 2 型糖尿病患者的随机对照试验,应用 ADA/EASD 共识的原则。

Optimizing Ramadan fasting: A randomised controlled trial for people with type 2 diabetes during Ramadan applying the principles of the ADA/EASD consensus.

机构信息

EDC, Centre for Diabetes Education, Charlotte, North Carolina, USA.

Diabetes Research Centre, University of Leicester, Leicester, UK.

出版信息

Diabetes Metab Res Rev. 2023 Mar;39(3):e3604. doi: 10.1002/dmrr.3604. Epub 2023 Jan 11.

DOI:10.1002/dmrr.3604
PMID:36547366
Abstract

BACKGROUND

Fasting during the holy month of Ramadan is one of the five pillars of Islam. Fasting is not meant to create excessive hardship on the Muslim individual according to religious tenets. It is important that health professionals are aware of potential risks associated with fasting during the month of Ramadan (mainly hypoglycemia and hyperglycemia).

AIMS

To explore the impact of applying the principles of our 2020 recommendations for the management of type 2 diabetes (T2D) during the month of Ramadan.

METHODS

A multinational randomized controlled trial (RCT) was conducted in five Muslim majority countries. Six hundred and sixty participants were deemed eligible for the study; however, 23% declined to participate later for various reasons. In total, 506 participants were enroled and were equally randomized to the intervention or the control group. At the end of the study, data from 231 participants in the intervention group and 221 participants from the control group were collected after 12.6% and 8.7% were, respectively, lost to follow-up. Participants were randomized to receive a Ramadan-focussed education with treatment for diabetes adjusted as per our 2020 recommendation update compared with the local usual care (control group). Results are presented using mean, standard deviation, odds ratio (OR), and percentages.

RESULTS

At the end of the study, the number of hypoglycemic episodes in the intervention group was less than in participants who received usual care. The intervention group had significantly lower severe hypoglycemia compared to the control group with an OR of 0.2 [0.1-0.8]. Compared to baseline, both groups had a significant reduction in glycated haemoglobin (HbA1c), but the improvements were significantly greater in the intervention group. Whilst body weight reduced and high-density lipoprotein cholesterol increased with the intervention, these changes were not significantly different from usual care.

CONCLUSIONS

A pre-Ramadan assessment of people with T2D coupled with pre-Ramadan education and an adjustment of glucose-lowering treatment as per our updated 2020 recommendations can prevent acute complications and allow a safer fast for people with T2D. We have shown that such an approach reduces the risk of developing severe hypoglycemia and improves the metabolic outcomes in people with T2D.

摘要

背景

在伊斯兰教的圣月斋月期间禁食是其五大支柱之一。根据宗教教义,禁食的目的并不是要给穆斯林个人带来过度的困难。重要的是,卫生专业人员应该意识到在斋月期间禁食可能带来的风险(主要是低血糖和高血糖)。

目的

探讨在斋月期间应用我们 2020 年关于 2 型糖尿病(T2D)管理建议的原则的影响。

方法

在五个穆斯林占多数的国家进行了一项多国随机对照试验(RCT)。共有 660 名参与者符合研究条件;然而,由于各种原因,23%的参与者后来拒绝参加。总共有 506 名参与者被纳入研究,并被平均随机分配到干预组或对照组。在研究结束时,收集了干预组 231 名参与者和对照组 221 名参与者的数据,分别有 12.6%和 8.7%的参与者因失访而无法获得数据。参与者被随机分配接受以斋月为重点的教育,并根据我们 2020 年的建议更新调整糖尿病治疗,与当地的常规护理(对照组)相比。结果以平均值、标准差、比值比(OR)和百分比呈现。

结果

在研究结束时,干预组的低血糖发作次数少于接受常规护理的参与者。与对照组相比,干预组的严重低血糖发生率显著降低,OR 为 0.2[0.1-0.8]。与基线相比,两组的糖化血红蛋白(HbA1c)均显著降低,但干预组的改善更为显著。虽然干预组的体重减轻和高密度脂蛋白胆固醇增加,但与常规护理相比,这些变化没有显著差异。

结论

在斋月前对 T2D 患者进行评估,结合斋月前教育,并根据我们最新的 2020 年建议调整降糖治疗,可以预防急性并发症,并为 T2D 患者提供更安全的斋戒。我们已经表明,这种方法可以降低发生严重低血糖的风险,并改善 T2D 患者的代谢结果。

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