Abstract:
BACKGROUND:Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care. METHODS:One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m2, treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice. DISCUSSION:This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed. TRIAL REGISTRATION:The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.
journal_name
BMC Endocr Disordjournal_title
BMC endocrine disordersauthors
van den Burg EL,Schoonakker MP,van Peet PG,van den Akker-van Marle ME,Willems van Dijk K,Longo VD,Lamb HJ,Numans ME,Pijl Hdoi
10.1186/s12902-020-00576-7subject
Has Abstractpub_date
2020-06-24 00:00:00pages
94issue
1issn
1472-6823pii
10.1186/s12902-020-00576-7journal_volume
20pub_type
杂志文章abstract:BACKGROUND:Diabetes mellitus (DM) leads to multiple complications, including severe hypoglycaemia events (SHEs). SHEs can impact a patient's quality of life and compliance and may directly result in additional costs to the health care system. The aim of this review was to evaluate the risk of severe hypoglycaemia in pa...
journal_title:BMC endocrine disorders
pub_type: 杂志文章,meta分析,评审
doi:10.1186/s12902-015-0052-z
更新日期:2015-10-12 00:00:00
abstract:BACKGROUND:Type 2 diabetes is a common and costly illness, associated with significant morbidity and mortality. Despite this, there is relatively little information on the 'real-world' medication utilization patterns for patients with type 2 diabetes initiating exenatide BID or glargine. The objective of this study was...
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
doi:10.1186/1472-6823-12-1
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pub_type: 杂志文章
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
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journal_title:BMC endocrine disorders
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pub_type: 杂志文章
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pub_type: 杂志文章,多中心研究
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pub_type: 杂志文章,评审
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