Evidence map›Paper›PMID 32580710›Full record

ArticleBMC endocrine disorders2020

Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes.

Elske L van den Burg, Marjolein P Schoonakker, Petra G van Peet, M Elske van den Akker-van Marle, Ko Willems van Dijk, Valter D Longo, Hildo J Lamb, Mattijs E Numans, Hanno Pijl

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC endocrine disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03811587 nacompletednot on this map

Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes

TypeinterventionalSponsorLeiden University Medical CenterRan2018 to 2021Enrolled100ConditionsDiabetes Mellitus, Type 2ArmsFasting Mimicking diet
NCT06518798 nacompletednot on this mapstarted 2024, after this paper: background citation

Pilot Study on Fasting-Mimicking Diet in Asian Americans With Prediabetes

TypeinterventionalSponsorUniversity of California, IrvineRan2024 to 2025Enrolled30ConditionsPrediabetes, Prediabetic StateArmsFasting Mimicking Diet
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Fasting: From Physiology to Pathology.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
    Review
  13. Article
  14. Fasting: How to Guide.Nutrients · 2021
    Article
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 3 countries.

Elske L van den BurgDepartment of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl.ORCID http://orcid.org/0000-0002-3149-5304
Marjolein P SchoonakkerDepartment of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
Petra G van PeetDepartment of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
M Elske van den Akker-van MarleDepartment of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.
Ko Willems van DijkInternal Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Valter D LongoFIRC Institute of Molecular Oncology, Milan, Italy.
Hildo J LambRadiology, Leiden University Medical Center, Leiden, the Netherlands.
Mattijs E NumansDepartment of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands.
Hanno PijlInternal Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Leiden University Medical Center · NLUniversity of Southern California · US

Funding

Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
NCATS NIH HHS UL1 TR001855
6 · The paper itself

Abstract

backgroundCaloric 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.

methodsOne hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m 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 registrationThe trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.

Indexed as

DietFastingQuality of LifeResearch DesignAdolescentAdultAgedBiomarkersBlood GlucoseDiabetes Mellitus, Type 2Early Medical InterventionFemaleFollow-Up StudiesGlycated HemoglobinHumansLife StyleBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanCost-effectivenessDiabetes mellitus, type 2Diet therapyFastingFasting-mimicking dietGlycated hemoglobin a

Identifiers

PMID32580710
PMCPMC7315472
OpenAlexW3037703114

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.