Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial

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

doi:10.1007/s00125-024-06137-0

Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial

Diabetologia. 2024 Mar 28. doi: 10.1007/s00125-024-06137-0. Online ahead of print.

Authors

Elske L van den Burg¹, Marjolein P Schoonakker², Petra G van Peet², Elske M van den Akker-van Marle³, Hildo J Lamb⁴, Valter D Longo^{5

6}, Mattijs E Numans², Hanno Pijl^{2

7}

Affiliations

¹ Department of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Leiden, the Netherlands. e.l.van_den_burg@lumc.nl.
² Department of Public Health and Primary Care, Leiden University Medical Centre (LUMC), Leiden, the Netherlands.
³ Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre (LUMC), Leiden, the Netherlands.
⁴ Department of Radiology, Leiden University Medical Centre (LUMC), Leiden, the Netherlands.
⁵ Longevity Institute, Davis School of Gerontology, University of Southern California, Los Angeles, CA, USA.
⁶ FIRC Institute of Molecular Oncology, Milan, Italy.
⁷ Department of Internal Medicine, Leiden University Medical Centre (LUMC), Leiden, the Netherlands.

PMID: 38546821
DOI: 10.1007/s00125-024-06137-0

Abstract

Aims/hypothesis: The aim of this study was to evaluate the impact on metabolic control of periodic use of a 5-day fasting-mimicking diet (FMD) programme as an adjunct to usual care in people with type 2 diabetes under regular primary care surveillance.

Methods: In this randomised, controlled, assessor-blinded trial, people with type 2 diabetes using metformin as the only glucose-lowering drug and/or diet for glycaemic control were randomised to receive 5-day cycles of an FMD monthly as an adjunct to regular care by their general practitioner or to receive regular care only. The primary outcomes were changes in glucose-lowering medication (as reflected by the medication effect score) and HbA_1c levels after 12 months. Moreover, changes in use of glucose-lowering medication and/or HbA_1c levels in individual participants were combined to yield a clinically relevant outcome measure ('glycaemic management'), which was categorised as improved, stable or deteriorated after 1 year of follow-up. Several secondary outcome measures were also examined, including changes in body weight.

Results: One hundred individuals with type 2 diabetes, age 18-75 years, BMI ≥27 kg/m², were randomised to the FMD group (n=51) or the control group (n=49). Eight FMD participants and ten control participants were lost to follow-up. Intention-to-treat analyses, using linear mixed models, revealed adjusted estimated treatment effects for the medication effect score (-0.3; 95% CI -0.4, -0.2; p<0.001), HbA_1c (-3.2 mmol/mol; 95% CI -6.2, -0.2 and -0.3%; 95% CI -0.6, -0.0; p=0.04) and body weight (-3.6 kg; 95% CI -5.2, -2.1; p<0.001) at 12 months. Glycaemic management improved in 53% of participants using FMD vs 8% of control participants, remained stable in 23% vs 33%, and deteriorated in 23% vs 59% (p<0.001).

Conclusions/interpretation: Integration of a monthly FMD programme in regular primary care for people with type 2 diabetes who use metformin as the only glucose-lowering drug and/or diet for glycaemic control reduces the need for glucose-lowering medication, improves HbA_1c despite the reduction in medication use, and appears to be safe in routine clinical practice.

Trial registration: ClinicalTrials.gov NCT03811587 FUNDING: The project was co-funded by Health~Holland, Top Sector Life Sciences & Health, the Dutch Diabetes Foundation and L-Nutra.

Keywords: Diet; Fasting-mimicking diet; Glucose-lowering medication; HbA1c, Lifestyle; Primary care; Randomised controlled trial; Therapy; Type 2 diabetes.

Associated data

ClinicalTrials.gov/NCT03811587