An interventional study of CH-rich diet with exercise and CH-reduced diet with exercise in Type 2 Diabetes, sponsored by Steno Diabetes Center Copenhagen. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
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.
Studies on T2D remission have reported varying rates of remission, often around 50% in intervention groups. These studies typically involve individuals with a recent T2D diagnosis, usually within six to ten years of diagnosis, with intervention periods most commonly lasting between twelve and twenty-four months, though durations have ranged from six to sixty months. Lifestyle interventions combining dietary changes and increased physical activity generally yield modest remission rates, but maintaining adherence over time remains challenging. Trials that include an initial phase of a very low-calorie diet, followed by ongoing structured support, tend to report higher remission rates. This emphasizes the critical role of significant and sustained weight loss. However, the most effective combination of dietary, exercise, and behavioral support strategies remains to be determined.
In addition to calorie restriction, changes in dietary composition may influence the underlying mechanisms of T2D. For instance, reducing carbohydrate intake can promote ketone production, affecting liver glucose production and improving glycemic control. Higher protein intake has been linked to an improved insulin response. Replacing saturated fats with polyunsaturated fats and increasing dietary fiber may also support glucose metabolism. However, it remains unclear whether carbohydrate-reduced or carbohydrate-rich diets are more effective in supporting long-term remission following initial weight loss.
Physical activity, particularly high-intensity exercise, plays a key role in reducing the risk of T2D, supporting weight management, and improving remission rates when combined with dietary interventions. Significant improvements in blood glucose control are usually seen with regular moderate-to-high-intensity exercise.
Moreover, there is considerable variation-or sometimes an absence-in the inclusion of key lifestyle intervention components, such as specific dietary and exercise protocols, as well as levels of supportive activities. This inconsistency complicates effective care provision for healthcare professionals and makes it difficult for individuals with T2D to adhere to non-pharmacological management recommendations.
Despite the known benefits of lifestyle modifications, initiating and maintaining these changes is challenging due to barriers such as a lack of support, motivation, and knowledge about nutrition and portion sizes. Involving individuals with T2D in designing and evaluating interventions may improve adherence, reduce participant burden, and increase the feasibility and scalability of lifestyle programs for wider implementation.
The overall aim of this study is to examine the feasibility of a 12-month, two-arm intervention designed to induce and maintain remission of T2D. After baseline measurements, participants will be randomized to one of two groups: Group A: Very-low-calorie-diet (VLCD)/weight loss followed by a carbohydrate-reduced (CH-reduced) diet combined with high-intensity exercise. Group B: VLCD/weight loss followed by a carbohydrate-rich (CH-rich) diet combined with high-intensity exercise. Participants and study staff will be blinded to the intervention arm during the VLCD phase.
To determine the optimal macronutrient composition of the Mixed Meal Tolerance Test (MMTT) for subsequent testing, participants will undergo three different MMTTs consisting of 550 kcal in random order at baseline; a low-carbohydrate meal (27/30/43 energy percentage (E%) from carbohydrate/protein/fat), an intermediate-carbohydrate meal (40/23/37 E%), and a high-carbohydrate meal (53/17/30 E%). Postprandial responses to the intermediate-carbohydrate meal will be evaluated against those to the low- and high-carbohydrate meal in terms of glucose, insulin, C-peptide, free fatty acids, and triglycerides during 240 minutes. If the responses are deemed sufficiently favorable, the intermediate-carbohydrate meal will be selected for MMTTs conducted at weeks 12, 18, and 52.
Feasibility will be evaluated based on the recruitment process, intervention acceptability, and participant adherence. This includes assessing whether the intervention components and outcome measurements are delivered and conducted as intended. Additionally, the study will examine how these elements perform in a real-life setting among individuals with T2D. Findings from this feasibility study will inform recruitment strategies, study design, and implementation of a subsequent five-arm, 24-month randomized controlled trial.
Specific aims:
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Building on previous findings from T2D remission studies involving VLCD interventions, the study include individuals with recently diagnosed T2D who are overweight or obese and not receiving insulin therapy. This subgroup has demonstrated the greatest benefit from significant weight loss. Participants using GLP-1 receptor agonists (GLP-1 RAs) are eligible, provided their weight has been stable for at least three months prior to inclusion. Individuals on insulin therapy will be excluded. Allowing GLP-1 RA use enhances the study's generalizability, as approximately 29% of people with T2D in Denmark are currently treated with these medications.
Inclusion Criteria:
Exclusion Criteria:
A CH-rich diet combined with an exercise programme (n=12)
Other: CH-rich diet with exercise
A CH-redcued diet combined with an exercise programme (n=12)
Other: CH-reduced diet with exercise
After 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.
After 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.
Time frame: Baseline, weeks 18, 24, 36, and 52.
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.
Time frame: 3 sessions pr. week, from week 13 to 52.
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.
Time frame: Through study completion, an average of 52 weeks.
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.
Time frame: Through study completion, an average of 52 weeks.
Feasibility testing of participant recruitment & retention
Registered numbers of: individuals expressing interest in the project, participants completing pre-screening (telephone interview) and in-person screening, participants included in the study, drop-outs and completers. Reasons for exclusion or withdrawal will be documented.
Time frame: Through study completion, an average of 52 weeks.
Feasibility testing of intervention participation - quantitative assessment
The degree of implementation of intervention activities and the extent of participant engagement will be measured by tracking attendance and completion of planned intervention components, including intervention visits, supervised and unsupervised exercise sessions, phone calls, at-home measurements, group-based education sessions, and peer support activities. Data will be collected via REDCap (8.10.18, Vanderbilt University, TN, USA) and study logs to quantify the proportion of completed versus scheduled activities for each participant.
Time frame: Through study completion, an average of 52 weeks.
Feasibility testing of intervention participation - qualitative assessment
Group-based diet and exercise sessions will be observed to assess how the intervention is delivered in practice and how participants engage with the activities. Field notes will document group dynamics, adherence to session protocols, and contextual factors. Field notes will also inform interview guides and supplement interview data.
Time frame: Through study completion, an average of 52 weeks.
Feasibility testing of protocol adherence - number of days with deviations
Total number of days during which participants did not adhere to the planned intervention protocol or experienced protocol deviations during the three intervention phases.
Time frame: Through study completion, an average of 52 weeks.
Feasibility testing of acceptability and experiences
Interviews with participants, dieticians and exercise instructors.
Time frame: Through study completion, an average of 52 weeks plus a 3-month follow-up interview with participants.
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.
Time frame: Every 2 weeks from week 15 to week 52.
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.
Time frame: Measured at baseline, weeks 18, 24, 36, and 52.
Diabetes remission
Number of participants with HbA1c \< 48 mmol/mol maintained for at least 3 months without glucose-lowering medication.
Time frame: Measured at weeks 12, 18, 30, 42, and 52.
Body weight (kg)
Measured to nearest 0.1 kg using a digital scale. Fasted state.
Time frame: Changes from baseline to the end of the intervention measured at four time points (baseline, weeks 12, 18, and 52).
Achieved clinically relevant weight loss (≥10%)
Number of participants who achieved a weight loss of at least 10% of their baseline body weight. Measured to nearest 0.1 kg using a digital scale. Fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
HbA1c (mmol/mol and %)
Assessed from blood samples collected in non-fasting state.
Time frame: Measured at screening, baseline, weeks 12, 18, 30, 42, and 52.
GAD65 Antibodies (U/mL)
Assessed from blood samples collected in non-fasting state.
Time frame: Measured at screening.
Marker of kidney function - eGFR (mL/min)
Estimated glomerular filtration rate (eGFR).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Creatinine (μmol/L)
Concentration of creatinine, assessed from blood sample in fasting state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Potassium (mmol/L)
Concentration of potassium, assessed from blood sample in fasting state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Sodium (mmol/L)
Concentration of sodium, assessed from blood sample in fasting state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Plasma Albumin (g/L)
Fasting concentration of plasma albumin.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Plasma Hemoglobin (g/L)
Fasting concentration of plasma hemoglobin.
Time frame: Measured at baseline, weeks 12, 18, and 52.
White Blood Cells (10⁹/L)
Fasting concentration of white blood cells.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Height (m)
Measured using a using an ultrasonic device to nearest 0.1 cm in order to calculate BMI.
Time frame: Measured at baseline.
Body weight (kg)
Measured to nearest 0.1 kg, in the morning, after urinating, before ad libitum diet acc to ad libitum intake of allocated intervention diet, using wireless scales at participants' home.
Time frame: Time frame: Collected once weekly from week 1 to 52.
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m). Fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Gut Microbiome Composition
Fecal samples will be analyzed for microbiome composition and diversity using 16S rRNA gene sequencing and shotgun metagenomic sequencing.
Time frame: Collected at baseline, weeks 12, 18, and 52.
Urine spot samples for dietary biomarkers (home collection)
Participants will collect three consecutive morning midstream urine samples and four additional spot urine samples at home. Urine samples will be analyzed by metabolomic profiling to quantify urinary concentrations of at least 10 dietary biomarkers, including Sulforaphane-N-acetylcysteine (broccoli), Proline betaine (citrus fruits), Carnosine (meat), and 3,5-dihydroxybenzoic acid glucuronides (whole grains).
Time frame: Collected at weeks 18, 24, 36, 42, and 52
Urine Albumin-to-Creatinine Ratio (at site)
Urine spot samples will be collected to assess renal function and diabetes-related kidney involvement.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Saliva microbiome composition
Saliva samples, analyzed for microbial composition changes via 16S rRNA and metagenomic.
Time frame: Collected at baseline, weeks 12, 18, and 52.
Metabolites - Mixed Meal Tolerance Test
Concentrations of metabolites including, but not limited to, glucose, triglycerides, free fatty acids (FFA), and alanine will be assessed during the MMTT at 8 time points; before the meal while fasting (minutes -15 and -5) and postprandially (minutes 30, 60, 90, 120, 180, and 240). Additionally, concentrations of lipoproteins and intact and split proinsulin will be measured in the fasting samples.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Glucometabolic and gut hormones (pmol/L and pmol/L*min) - Mixed Meal Tolerance Test
Optionally, concentrations of hormones involved in glucose and lipid metabolism and appetite regulation including insulin, glucagon, C-peptide, GLP-1, GIP, ghrelin, PYY, CCK and more variables will be assessed during the MMTT at 8 time points; before the meal while fasting (minutes -15 and -5) and postprandially (minutes 30, 60, 90, 120, 180, and 240). Results will be expressed in pmol/L. Area under the curve (AUC) will be expressed as pmol/L\*min.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Insulin Sensitivity - Mixed Meal Tolerance Test
Insulin sensitivity will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
β-Cell Function - Mixed Meal Tolerance Test
β-cell function will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Hepatic First-Pass Insulin Extraction - Mixed Meal Tolerance Test
Hepatic first-pass insulin extraction will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Metabolic Insulin Clearance - Mixed Meal Tolerance Test
Metabolic insulin clearance will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Subjective appetite sensations - Mixed Meal Tolerance Test
Rated using visual analogue scales (VAS) and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, or sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before". VAS ratings are collected at 7 time points during the MMTT; before the meal while fasting (minute -10) and postprandially (minutes 30, 60, 90, 120, 180, 240).
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Physical activity
Physical activity (PA) including but limited to: PA (time spent at different intensities (sedentary activity, low light activity, high light activity, moderate to vigorous activity, vigorous activity), PA (total counts, counts/min), PA energy expenditure (kcal/day), PA (MET hours) and timing of PA (hh:mm) will be objectively assessed using a thigh-mounted accelerometer (SENS Motion). Participants will wear the device 24 hours/day for 10 consecutive days prior to visits. Data will provide time-stamped estimates of sedentary time, time spent standing, walking, bicycling, and intensity of movement.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Waist circumference (cm)
Measured using tape measure to the nearest 0.5 cm. Fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Hip circumference (cm)
Measured using tape measure to the nearest 0.5 cm. Fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Waist/hip ratio
The ratio of the circumference of the waist to that of the hips.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Fat mass (kg)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Fat free mass (kg)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Fat percentage (%)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Bone mass (kg)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - Degree of liver fibrosis (kPa)
Measured by FibroScan in a fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - Degree of liver steatosis (dB/m)
Measured by FibroScan in a fasted state.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - FIB-4 Index
Will be calculated from participants' age and fasting concentration of aspartate-aminotransferase (U/L), alanine-aminotransferase (U/L) and thrombocytes (x10\^9/L).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Cognition
Cognitive functions will be assessed by Screen for Cognitive Impairment in Psychiatry Danish Version (SCIP-D) together with the Trail Making Test Part B (TMT-B, psychomotor speed and executive function).
Time frame: Measured at baseline, weeks 12, and 52.
Food choice - Food preferences and food reward
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Food attention - Food preferences and food reward
Measured using eye tracking in response to looking at food pictures during Steno Biometric Food Preference Task (SBFPT). Includes the following parameters: Gaze: Time spent (ms and %) and visits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score \>0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score \<0.5 indicates attention towards the other food images.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Food reaction time (ms) - Food preferences and food reward
Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fatsavoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Explicit liking - Food preferences and food reward
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savouryand low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this foodright now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Implicit wanting - Food preferences and food reward
Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm). In this frequency-weighted algorithm a positive score indicates a morerapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm isused so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixedmin-max value).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Explicit wanting - Food preferences and food reward
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Unspecified exploratory outcome - Food preferences and food reward
Unspecified exploratory outcomes related to the 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Systolic blood pressure (mmHg)
Measured under resting and fasting conditions.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Diastolic blood pressure (mmHg)
Measured under resting and fasting conditions.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Resting heart rate (bpm)
Measured under resting and fasting conditions.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Cardiac rhythm (ECG)
A standard 12-lead resting ECG will be performed to assess cardiac rhythm and detect potential contraindications for maximal exercise testing. This screening is conducted to ensure participant safety prior to performing the VO₂ peak test.
Time frame: Measured at baseline.
Peak oxygen uptake (ml O2/min)
Peak oxygen consumption (VO2peak) as a measure of cardiorespiratory fitness will be measured by an incremental bicycle ergometer test.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Cardiorespiratory fitness (ml O2/min/kg)
Peak oxygen consumption (VO2peak) per kg body weight as a measure of cardiorespiratory fitness. Measured by an incremental bicycle ergometer test.
Time frame: Measured at baseline, weeks 12, 18, and 52.
Time-in-range (% 3.9-10.0 mmol/L)
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Time frame: Measured at baseline, weeks 1 and 51.
Time-below-range (% <3.9 mmol/L)
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Time frame: Measured at baseline, weeks 1 and 51.
Time-above-range (% >10.0 mmol/L)
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Time frame: Measured at baseline, weeks 1 and 51.
Coefficient of variation (CV) of glucose concentrations
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Time frame: Measured at baseline, weeks 1 and 51.
Heart rate (bpm)
Assessed from GPS-based smart watch.
Time frame: Measured from weeks 16 to 51 during exercise sessions.
Self-reported quality of life
Assessed using the Quality of Life (12-Item Short Form Survey, SF-12), which measures health-related quality of life across physical and mental health domains. The questionnaire includes 12 items and yields two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better health status. A PCS score of 50 or below may indicate physical health impairment, while an MCS score of 42 or below may suggest clinical depression.
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported health-related quality of life
Assessed from the questionnaire European Quality of Life - 5 Dimensions (EQ-5D). EQ-5D comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 3 or 5 levels of severity. A health utility index score is derived, ranging from values below 0 (where 0 represents death and negative values represent states worse than death) to 1 (full health). Higher scores indicate better health-related quality of life.
Time frame: Measured at baseline, weeks 12 and 52.
Changes in sum score of The 25-item Bodily Distress Syndromes (BDS) checklist
Measure of severity of symptom burden. The number of non-missing (answered) items in the 25-item Bodily Distress Syndromes (BDS) checklist (from bds1 to bds25) is counted for each individual to determine if enough data is available to compute a score. Then, if at least 13 items are answered, the average of the available responses is calculated, scaled to a 0-100 range, rounded to the nearest whole number, and saved as the BDS sum score. Lower value is better.
Time frame: Measured at baseline, weeks 12 and 52.
Changes in symptom cases
For each of the following domains: cardiopulmonary symptoms (b1-b6), gastrointestinal symptoms (b7-b13), musculoskeletal symptoms (b14-b20) and general symptoms (b21-b25).Bimodal variable for cases - Number of symptoms scored above 1 (including Somewhat, Quite a bit \& A lot). Participants reporting ≥4 such symptoms and with fewer than 3 missing responses will be classified as a case being at least four symptoms within each domain (binary variable: 1 = case, 0 = non-case).
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported diabetes distress
Assessed from the Problem Areas in Diabetes Scale (PAID-5 scale) comprising five of the emotional-distress questions of the full PAID items. Each item can be rated from 0 to 4. A total score of ≥8 indicates possible diabetes related emotional distress.
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported loneliness
Assessed from the questionnaire The Three Item Loneliness Scale (TILS). TILS consists of 3 items assessing subjective feelings of loneliness and social isolation. Scores range from 3 to 9, with higher scores indicating greater loneliness. A score of 6 or above has been used as a cut-off to indicate elevated loneliness in population-based studies.
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported sleep quality
Assessed from the questionnaire Pittsburgh Sleep Quality Index. The questionnaire consists of 19 items. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported self-efficacy for nutrition change
Assessed from the questionnaire Self-efficacy for nutrition change (SEFNC). SEFNC assesses individuals' confidence in their ability to maintain healthy eating habits in challenging situations over the next six months. The scale includes 9 items addressing common barriers such as emotional distress, lack of support, time pressure, and disrupted routines. Each item is rated on a percentage scale from 0% ("Not at all confident") to 100% ("Completely confident"), in 10% increments. A higher mean score indicates greater self-efficacy for sustaining nutrition-related behavior change.
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported social support for eating habits
Assessed from the questionnaire Social Support for Eating Habits Questionnaire. The questionnaire includes 10 items rated separately for family and friends, assessing both supportive and unsupportive behaviors related to dietary change. Items are rated on a scale from 1 (Not at all) to 5 (Very often), with 8 indicating "Not applicable." Higher scores on supportive items reflect greater perceived support; higher scores on unsupportive items reflect greater social barriers.
Time frame: Measured at baseline, weeks 12 and 52.
Self-reported food addiction
Assessed from the questionnaire Yale food addiction scale (YFAS). It consists of 25 items evaluating symptoms such as loss of control over eating, continued use despite negative consequences, and withdrawal. The scale provides both a symptom count score (ranging from 0 to 11) and a diagnostic threshold indicating the presence of food addiction. Higher scores indicate more severe food addiction symptomatology. A diagnosis is assigned if a certain number of symptoms are endorsed along with clinically significant impairment or distress
Time frame: Measured at baseline, weeks 12 and 52.
Adverse events
Number and description of adverse events and serious adverse events reported during the intervention period.
Time frame: Through study completion, an average of 52 weeks.
Exercise intensity (%VO2peak)
Heart rate assessed from GPS-based smart watch and corresponding %VO2peak (measured at test visits).
Time frame: Measured at baseline, weeks 12, 18, and 52.
Exercise intensity (Rate of Perceived Exertion Scale)
Rate of perceived Exertion on a 0 to 10 scale (0 being no exertion at all and 10 being a maximum effort).
Time frame: 3 sessions pr. week, from week 13 to week 52.
Cardiac output - Mixed Meal Tolerance Test
Cardiac output (L/min) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Systemic vascular resistance - Mixed Meal Tolerance Test
Systemic vascular resistance (dyn\*s/cm5) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Heart rate and its variability - Mixed Meal Tolerance Test
Heart rate (bpm) and heart rate variability (ms) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Blood pressure and its variability - Mixed Meal Tolerance Test
Blood pressure and blood pressure variability (mmHg) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Timing - sleep pattern
Sleep timing (hh:mm) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Time frame: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18, and 52 (SENS Motion).
Duration - sleep pattern
Sleep duration (minutes) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Time frame: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Variability - sleep pattern
Sleep variability (minutes) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Time frame: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Efficiency - sleep pattern
Sleep efficiency (%) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Time frame: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Wakefulness - sleep pattern
Sleep wakefulness (%) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Time frame: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Home blood pressure
Systolic and diastolic blood pressure (mmHg) will be measured at home under resting conditions.
Time frame: Measured at baseline, at weeks 1, 2, 3, 4, 8, 12, 18, 24, 30, 36, 42, 48, and 52.
Resting heart rate measured at home
Resting heart rate (bpm) will be measured at home under resting conditions
Time frame: Measured at baseline, at weeks 1, 2, 3, 4, 8, 12, 18, 24, 30, 36, 42, 48, and 52.
Self-measured blood glucose
Capillary blood glucose (mmol/L) will be measured at home before the three main meals and at bedtime over two consecutive days.
Time frame: Measured at baseline, at weeks 1, 2, 3, 4, 8, 12, 18, 24, 30, 36, 42, 48, and 52.
Plan to share: No
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Steno Diabetes Center Copenhagen