A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes

NCT07262788 | Recruiting

• 1 other identifier: 1-10-72-77-25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Obesity; Remission; Feasibility; Diet; Overweight; Lifestyle Intervention; Exercise

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Through study completion, an average of 52 weeks.

• Feasibility testing of acceptability and experiences

  Interviews with participants, dieticians and exercise instructors.

  Through study completion, an average of 52 weeks plus a 3-month follow-up interview with participants.

Secondary Outcomes (83)

• Evaluation of dietary screener to assess adherence

  Every 2 weeks from week 15 to week 52.

• Dietary intake

  Measured at baseline, weeks 18, 24, 36, and 52.

• Diabetes remission

  Measured at weeks 12, 18, 30, 42, and 52.

• Body weight (kg)

  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%)

  Measured at baseline, weeks 12, 18, and 52.

Study Arms (2)

CH-rich diet with exercise

EXPERIMENTAL

A CH-rich diet combined with an exercise programme (n=12)

Other: CH-rich diet with exercise

CH-reduced diet with exercise

EXPERIMENTAL

A CH-redcued diet combined with an exercise programme (n=12)

Other: CH-reduced diet with exercise

Interventions

CH-rich diet with exercise OTHER

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.

CH-rich diet with exercise

CH-reduced diet with exercise OTHER

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.

CH-reduced diet with exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Body weight changes over 3 months ≤3 kg

You may not qualify if:

• 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)
• Physical comorbidity, which precludes the physical activity during intervention
• Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions
• Unable to comply with trial procedures and/or interventions
• Alcohol/drug abuse
• Planned or present pregnancy/fertility treatment, or lack of contraception during reproductive age
• Unstable psychiatric disease that is deemed to impede participation in the project
• Diagnosed with binge eating disorder
• Participation (present or planned) in other clinical trials including lifestyle or pharmacy trials for any condition
• If HbA1c ≥60 mmol/mol and the participant is on 2 or more anti-diabetic drugs and has a positive GAD65 and/or stimulated C-peptide \<800 pM

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• 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

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jonas Salling Quist Senior Researcher and Associate Professor, PhD

  Steno Diabetes Center Copenhagen, University of Copenhagen - Department of Biomedical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Salling Quist Senior Researcher and Associate Professor, PhD

CONTACT

+45 26176064; jonas.salling.quist@regionh.dk

Anne-Ditte Termannsen Project Manager, PhD

CONTACT

+4551209970; anne-ditte.termannsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher and Associate Professor

Model Details: The feasibility study is a 52-week, 2-arm open-label randomized diet and exercise trial including 24 individuals with newly diagnosed type 2 diabetes.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: December 4, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)