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British Journal of General Practice

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Study design of the Fasting In diabetes Treatment (FIT) trial: a randomised, controlled, assessor blinded intervention trial which examines the effect of intermittent use of a fasting mimicking diet in patients with type 2 diabetes

Elske van den Burg, Marjolein Schoonakker, Elske van den Akker, Ko Willems van Dijk, Hildo Lamb, Hanno Pijl, Mattijs Numans and Petra van Peet
British Journal of General Practice 2020; 70 (suppl 1): bjgp20X711173. DOI: https://doi.org/10.3399/bjgp20X711173
Elske van den Burg
Public Health and Primary Care, Leiden University Medical Center
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Marjolein Schoonakker
Public Health and Primary Care, Leiden University Medical Center
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Elske van den Akker
Medical Decision Making, Leiden University Medical Center
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Ko Willems van Dijk
Human Genetics, Leiden University Medical Center
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Hildo Lamb
Radiology, Leiden University Medical Center
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Hanno Pijl
Internal Medicine, Leiden University Medical Center
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Mattijs Numans
Public Health and Primary Care, Leiden University Medical Center
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Petra van Peet
Public Health and Primary Care, Leiden University Medical Center
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Abstract

Background Caloric restriction is an effective way to treat type 2 diabetes (DM2). However, chronic restriction of food intake is difficult to sustain. Intermittent total fasting exerts similar metabolic effects, but may be even more challenging for most patients. A fasting mimicking diet (FMD) was designed to achieve the metabolic benefits of total fasting, despite considerable calorie content. The effects of a FMD in DM2 patients are still unknown.

Aim To determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in DM2 patients on metabolic parameters and DM2 medication use compared to usual care.

Method One hundred DM2 patients from general practices in the Netherlands with a BMI ≥ 27 kg/m2, treated with lifestyle advice only or metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and DM2 medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome, MRI (for example, cardiac function and fat distribution), cost-effectiveness, and feasibility in clinical practice.

Results The first 70 patients are included. Follow up will be completed in April 2021.

Conclusion Our results will show whether monthly cycles of a FMD are feasible in clinical practice, if they improve metabolic parameters and/or reduce the need for medication in DM2 and if this is a cost-effective intervention.

  • © British Journal of General Practice 2020
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British Journal of General Practice: 70 (suppl 1)
British Journal of General Practice
Vol. 70, Issue suppl 1
June 2020
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Study design of the Fasting In diabetes Treatment (FIT) trial: a randomised, controlled, assessor blinded intervention trial which examines the effect of intermittent use of a fasting mimicking diet in patients with type 2 diabetes
Elske van den Burg, Marjolein Schoonakker, Elske van den Akker, Ko Willems van Dijk, Hildo Lamb, Hanno Pijl, Mattijs Numans, Petra van Peet
British Journal of General Practice 2020; 70 (suppl 1): bjgp20X711173. DOI: 10.3399/bjgp20X711173

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Study design of the Fasting In diabetes Treatment (FIT) trial: a randomised, controlled, assessor blinded intervention trial which examines the effect of intermittent use of a fasting mimicking diet in patients with type 2 diabetes
Elske van den Burg, Marjolein Schoonakker, Elske van den Akker, Ko Willems van Dijk, Hildo Lamb, Hanno Pijl, Mattijs Numans, Petra van Peet
British Journal of General Practice 2020; 70 (suppl 1): bjgp20X711173. DOI: 10.3399/bjgp20X711173
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Print ISSN: 0960-1643
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