Elske van den Burg¹, Marjolein Schoonakker¹, Petra van Peet¹, Mattijs Numans¹, Hanno Pijl^1,2, Hildo Lamb³

(1) Public Health and Primary Care; (2) Internal Medicine; (3) Radiology. Leiden University Medical Centre, Leiden, The Netherlands. e.l.van_den_burg@lumc.nl

Background

The aim was to assess effects of a fasting-mimicking diet (FMD) programme for 5-consecutive days per month for twelve months in patients with type 2 diabetes on liver fat, measured by proton density fat-fraction (PDFF), and liver inflammation/fibrosis, measured by iron-corrected T1 (cT1). PDFF is an accurate MRI-derived biomarker for liver fat quantification that is routinely used in clinical research. cT1 has been found to correlate with histopathological features of metabolic dysfunction-associated steatohepatitis (MASH), and can be used as a MRI-derived biomarker for inflammation/fibrosis. cT1 is associated with a higher risk of incident cardiovascular disease.

Methods

Here we report secondary outcome measures of the Fasting In diabetes Treatment (FIT) trial, which was a randomised, controlled, assessor-blinded trial in which people with type 2 diabetes using metformin only and/or diet alone for glycaemic control were randomised to receive 5-consecutive day cycles of an FMD monthly as adjunct to usual care or usual care only for twelve months. Laboratory measurements and MRI were performed at baseline, 6 months and 12 months.

Results

Data were available of 89 participants who completed the baseline visits of the FIT trial, including MRI. Intention-to-treat analyses, using linear mixed models, revealed significant adjusted estimated treatment effects of the FMD on PDFF (-2.8%, 95% CI -4.7 to -0.8, p<0.01) and cT1 (-29.9 ms, 95% CI -51.8 to -8.0, p<0.01) at 12 months.

Discussion/Conclusion

Following an FMD programme for 5-consecutive days per month for twelve months reduces both liver PDFF and cT1 MRI-derived biomarkers in patients with type 2 diabetes, indicating a reduction in liver fat and liver inflammation/fibrosis. Monthly cycles of an FMD appear to be a valuable adjunct to regular treatment of type 2 diabetes.