Mediterranean diet and time-restricted eating as a cardiac rehabilitation approach for patients with coronary heart disease and pre-diabetes: the DIABEPIC-1 protocol of a feasibility trial.

INTRODUCTION: Despite proven programmes, implementing lifestyle interventions for pre-diabetes and type 2 diabetes is challenging. Cardiac rehabilitation, provide a valuable opportunity to promote the adoption of healthy lifestyle behaviours for patients with atherosclerotic cardiovascular disease (ASCVD). However, only a limited number of studies have explored the potential for reversing the underlying causes of ASCVD in this setting. OBJECTIVES: The DIABEPIC1 study is an ongoing single-arm lifestyle clinical trial to assess the feasibility of an upgraded 6-month intensive cardiac rehabilitation programme combining an innovative diet assignment with exercise training to reverse newly onset pre-diabetes (glycated haemoglobin 5.7%-6.4%) to normal glucose concentrations in patients with coronary heart disease. METHODS AND ANALYSIS: 36 patients referred from the Montreal Heart Institute for cardiac rehabilitation, aged ≥40 years with a recent diagnosis of pre-diabetes in the last 6 months, will be offered to participate in the upgraded programme. Interventions will include four sessions of nutritional counselling on ultra-processed foods intake reduction and a moderate-carbohydrate (<40%) ad libitum Mediterranean diet coupled with 36 1-hour sessions of supervised exercise training (continuous and interval aerobic training, and resistance training) and educational intervention. Phase 2 will continue the same interventions adding 8:16 hour time-restricting eating (TRE) at least 5 days per week. During this second phase, exercise training will be performed with autonomy. The primary objectives will be to evaluate the recruitment rate, the completion rates at 3 and 6 months, and the compliance of participants. The secondary objectives will be to assess the proportion of prediabetic participants in remission of pre-diabetes at the programme's end and to characterise the factors associated with remission. ETHICS AND DISSEMINATION: The DIABEPIC1 feasibility study is approved by the Research Ethics Board of the Montreal Heart Institute (Project Number ICM 2022-3005). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. CONCLUSIONS: The DIABEPIC1 trial will examine the feasibility and effectiveness of an enhanced cardiac rehabilitation programme combining exercise training with an ultra-processed food reduction intervention, a Mediterranean diet, and TRE counselling to remit pre-diabetes to normal glucose concentrations. TRIAL REGISTRATION NUMBER: NCT05459987.

Metabolic Improvements and Remission of Prediabetes and Type 2 Diabetes: Results From a Multidomain Lifestyle Intervention Clinic.

OBJECTIVES: Although lifestyle interventions are first-line treatment for individuals living with prediabetes and type 2 diabetes (T2D), they are rarely implemented effectively in routine clinical care. METHODS: We present a retrospective analysis of a 12-month, single-centre, structured multidomain lifestyle intervention clinic offered to individuals living with prediabetes and type 2 diabetes. The intervention consisted of expert-guided educational and nutritional counselling combined with a personalized physical exercise prescription, with the main goal of improving metabolic health and reaching remission. Anthropometric parameters, glucose, basal insulin, glycated hemoglobin (A1C), and lipid levels were measured at baseline and at 3, 6, and 12 months after the lifestyle intervention initiation. Remission of prediabetes and T2D were defined as a return of A1C at 6 months to <6.5% (or <5.7% for prediabetes) and persisting for at least 3 months in the absence of glucose-lowering pharmacotherapy. RESULTS: After a multidomain, expert-guided lifestyle intervention, 117 individuals living with prediabetes and T2D had significantly improved metabolic profiles: Mean weight change at 12 months was -4.9 kg (95% confidence interval [CI], -4.0 to -5.7; p<0.001), and mean change in A1C at 12 months was -0.6% (95% CI, -0.4 to -0.7; p<0.001). A substantial proportion of individuals reached the criteria for remission (20% among participants with prediabetes and 12% among those with T2D). CONCLUSIONS: The results of this study suggest that prioritizing lifestyle changes in a multifaceted, progressive, 12-month intervention in this population improves anthropometric and insulin resistance measures, and has the potential to normalize metabolic values, even to the point of reaching the criteria of remission.