医学监督下禁食对2型糖尿病患者维生素D、血糖控制、生活质量和药物需求的影响:随机对照试验方案(FAVIT试验)

Pradeep M. K. Nair, Karishma Silwal, Prakash Babu Kodali, Hemanshu Sharma, Gulab Rai Tewani
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引用次数: 0

摘要

摘要目的探讨延长医学监督禁食(PMSF) 6个月对2型糖尿病(T2DM)患者维生素D水平和糖尿病相关临床结局的影响。方法:这是一项开放标签、平行对照、随机对照试验;来自补充医学环境的170例T2DM患者,年龄在20至70岁之间,体重指数为25 kg/ m2,糖化血红蛋白(HbA1C)水平为6%至12%,接受生活方式建议和/或口服降糖药治疗,随机接受PMSF或糖尿病饮食(DD),以及他们的常规护理。患者最初将在研究环境中接受为期10天的PMSF和DD培训,然后在各自的住所进行5个月的实践。在首次接触后,PMSF组将每月禁食五天,连续三个月,而DD组将遵循相同的饮食6个月。除禁食日外,PMSF组将遵循与对照组相同的DD。主要结局是维生素D水平的改善,次要结局包括血清钙、胰岛素水平、胰岛素抵抗、血细胞计数、人体测量、生活质量、用药评分、依从率和疾病感知。在本研究中,我们假设PMSF会逐渐增加维生素D水平,从而增加钙水平,从而促进胰岛素分泌并上调其功能。这可能有助于减少对糖尿病药物的需求,并导致糖尿病缓解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impact of medically supervised fasting on the vitamin D, glycemic control, quality of life and need for medication among type 2 diabetes mellitus: Protocol for a randomized control trial (FAVIT Trial)
Abstract Objective The objective of this study is to investigate the effect of prolonged medically supervised fasting (PMSF) for 6 months on vitamin D levels and diabetes-related clinical outcomes in type 2 diabetes mellitus (T2DM) patients. Methods This is an open-label, parallel arm, randomized control trial; 170 T2DM patients from a complementary medicine setting, aged between 20 and 70 years, with a body mass index >25 kg/m2 and glycated hemoglobin (HbA1C) levels >6% and <12%, treated with lifestyle advice and/or oral hypoglycemic drugs, will be randomized to receive PMSF or a diabetic diet (DD), along with their usual care. The patients will be initially trained in PMSF and DD for a duration of 10 days in the study setting, followed by 5 months of practice at their respective residences. The PMSF will fast for five days a month for three consecutive months after the initial exposure, whereas the DD group will follow the same diet for 6 months. Other than fasting days, the PMSF group will follow the same DD as the control group. The primary outcome is an improvement in vitamin D levels, and the secondary outcomes include serum calcium, insulin levels, insulin resistance, blood cell counts, anthropometrics, quality of life, medication score, compliance rate, and disease perception. Discussion In this study, we hypothesize that PMSF would gradually increase vitamin D levels, which would increase calcium levels, which would promote insulin secretion and upregulate its function. This may help reduce the need for diabetic medication and result in diabetic remission.
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