Optimizing cardiovascular health with a type 2 diabetes remission program: Ultraprocessed food-intake reduction, Mediterranean diet, chrononutrition and physical training-The DIABEPIC-2 pilot study.

Abstract

Aims: The possibility of type 2 diabetes (T2D) remission following very-low caloric restriction has been demonstrated. However, the feasibility of T2D remission following other health behavioural interventions remains to be explored.

Materials and methods: The DIABEPIC-2 pilot study assessed the feasibility of a 6-month programme based on ultra-processed food intake reduction, a Mediterranean diet, and physical training. Also, a randomised 2:1 proportion of participants added intermittent fasting (IF) in the last 3 months. The study explored the T2D remission rate and its impact on cardiometabolic and anthropometric parameters, cardiorespiratory fitness, and quality of food matrix.

Results: Feasibility was demonstrated with a recruitment rate of 6.4 participants/month, 34 participants (81%) who completed the programme, with an 87% attendance rate (63.6 ± 9.2 years old, initial mean HbA1c of 6.7 ± 0.7%, mean T2D duration of 7.4 ± 6.7 years). At 6 months, participants had a mean weight loss of -6.8 kg (-9.3 to -4.4, p < 0.001), and 13 participants out of 34 (38%) achieved T2D remission. Overall, participants significantly improved cardiometabolic health and anthropometric parameters, cardiorespiratory fitness, and food matrix quality. Participants randomised to the IF add-on intervention group did not show significant additional improvement.

Conclusion: The DIABEPIC-2 program enabled a significant proportion of participants to achieve T2D remission and to improve their cardiovascular health; therefore, it would be relevant to confirm these results. The recruitment and visit completion rates observed in this pilot study further demonstrate its feasibility, supporting the rationale for conducting a larger randomized clinical trial.