The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.
Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication
HbA1c between 36-86 mmol/mol
T2D duration of ≤6 years
BMI ≥27 kg/m2
Insulin treatment within 6 months prior to screening (any type)
Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
Kidney disease (eGFR <60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
Parallel
CH-rich diet with exercise
Other interventionAfter 12 weeks of following a VLCD (Phase 1), participants begin a 6-week transition (Phase 2). During this phase, they adopt a CH-rich diet, consuming 50-55% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity \>70% peak oxygen uptake (VO2peak) and/or \>7 on the Rate of Perceived Exertion scale (RPE), equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session per week.
CH-reduced diet with exercise
Other interventionAfter 12 weeks of following a VLCD (Phase1), participants begin a six-week transition (Phase 2 ). During this phase, they adopt a CH-reduced diet, consuming 25-30% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity \>70% peak oxygen uptake (VO2peak) and/or \>7 on the RPE scale, equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session peer week.
Feasibility testing of diet adherence
Derived from myfood24 dietary recalls collected over three consecutive days at pre-specified time points. A recall day is adherent if E% carbohydrate is within the arm-specific target ±10 E%. Participant-level percent compliance at each time point is calculated as (adherent recall days / valid recall days) × 100.
Feasibility testing of exercise adherence
Adherence is assessed based on self-report and measured (wearable heart rate monitor) using study app and calculated as number of completed sessions / total prescribed sessions.
Feasibility testing of GP recruitment & safety procedures - quantitative assessment
The recruitment of GPs will be assessed based on the number who express interest, attend instruction and sign collaboration agreements. The reasons for GP non-participation or withdrawal will be documented and, if possible, the GPs will be interviewed. Contacts with GPs that are safety-related, and their responses, including the outcomes of medication changes, will be recorded.
Feasibility testing of GP experiences and study procedures - qualitative assessment
Interviews with one GP or staff member from each participating clinic will explore experiences with study procedures, including barriers and opportunities related to recruitment and medication discontinuation, as well as any unintended consequences.
Evaluation of dietary screener to assess adherence
A dietary screener will be used to generate a binary off-track flag to enable timely dietitian outreach when participants may need support to improve adherence during the study period. As part of the dietary screener, participants will complete an overall self-assessment of adherence to their allocated diet during the past 7 days. Participant ratings will be compared with the dietitian's adherence rating following flagged checks, and interrater agreement (participant vs. dietitian) and agreement with MyFood24-derived adherence will be explored.
Dietary intake
Dietary intake, including energy intake (kcal/day) and macronutrient intake (total in grams and E% per day) and micronutrient intake (units/day) based on 3-days' dietary recalls based on MyFood24.
Diabetes remission
Number of participants with HbA1c \< 48 mmol/mol maintained for at least 3 months without glucose-lowering medication.
Body weight (kg)
Measured to nearest 0.1 kg using a digital scale. Fasted state.
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Steno Diabetes Center Copenhagen
Lead sponsor
Aarhus University Hospital
Collaborator
Steno Diabetes Center Odense
Collaborator
University of Copenhagen
Collaborator
The Novo Nordisk Foundation Center for Basic Metabolic Research
Collaborator
Bispebjerg Hospital
Collaborator
