A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes (ON LiMiT)
Study tests lifestyle changes for Type 2 Diabetes remission
Plain English Summary
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes is a Not Applicable clinical trial sponsored by Steno Diabetes Center Copenhagen studying Type 2 Diabetes. This study tests if a 12-month lifestyle program can help people with Type 2 Diabetes achieve and maintain remission. It is for adults recently diagnosed with Type 2 Diabetes who are overweight or obese and not on insulin. Participation involves following a specific diet and exercise plan, with regular check-ins. Alternatives include standard diabetes management with medication and ongoing lifestyle advice from a doctor. The trial aims to enroll 24 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have Type 2 Diabetes diagnosed within the last 6 years, a BMI of 27 or higher, and are not using insulin. You cannot join if you are currently on insulin, have certain heart or kidney conditions, or have a history of binge eating disorder. Participants must be between 18 and 75 years old and able to commit to the program's physical activity requirements. Specific health conditions like heart failure or significant kidney disease may exclude you. This trial is studying Type 2 Diabetes, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will show how well participants can stick to the diet and exercise plan, and how safely the program can be delivered, indicating its potential for future larger studies. The specific primary outcome measures are: Feasibility testing of diet adherence (Baseline, weeks 18, 24, 36, and 52.); Feasibility testing of exercise adherence (3 sessions pr. week, from week 13 to 52.); Feasibility testing of GP recruitment & safety procedures - quantitative assessment (Through study completion, an average of 52 weeks.); Feasibility testing of GP experiences and study procedures - qualitative assessment (Through study completion, an average of 52 weeks.); Feasibility testing of participant recruitment & retention (Through study completion, an average of 52 weeks.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores a non-drug approach to potentially reverse Type 2 Diabetes, addressing a significant need for effective remission strategies. This research targets Type 2 Diabetes, where improved treatment options are needed.
Investor Insight
This feasibility study signals investor interest in non-pharmacological approaches for Type 2 Diabetes, a large market with a growing demand for remission-focused treatments.
Is This Trial Right for Me?
Ask your doctor if this lifestyle intervention is suitable for your specific health situation and diabetes management. Be prepared for a structured diet and exercise program, which may involve initial very low-calorie intake followed by specific meal plans and regular physical activity. Understand that the study involves regular visits and assessments to monitor your progress and safety throughout the 12 months. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 24 participants
Interventions
- OTHER: CH-rich 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 on
- OTHER: CH-reduced diet with exercise — 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 a
Primary Outcomes
- Feasibility testing of diet adherence (Baseline, weeks 18, 24, 36, and 52.)
- Feasibility testing of exercise adherence (3 sessions pr. week, from week 13 to 52.)
- Feasibility testing of GP recruitment & safety procedures - quantitative assessment (Through study completion, an average of 52 weeks.)
- Feasibility testing of GP experiences and study procedures - qualitative assessment (Through study completion, an average of 52 weeks.)
- Feasibility testing of participant recruitment & retention (Through study completion, an average of 52 weeks.)
Secondary Outcomes
- 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.)
Full Eligibility Criteria
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: * 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 Exclusion Criteria: * 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
Trial Locations
- Steno Diabetes Center Copenhagen, Herlev, Denmark, Denmark
Frequently Asked Questions
What is clinical trial NCT07262788?
NCT07262788 is a Not Applicable INTERVENTIONAL study titled "A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes." It is currently recruiting and is sponsored by Steno Diabetes Center Copenhagen. The trial targets enrollment of 24 participants.
What conditions does NCT07262788 study?
This trial investigates treatments for Type 2 Diabetes. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT07262788?
The interventions being studied include: CH-rich diet with exercise (OTHER), CH-reduced 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 on
What does Not Applicable mean for NCT07262788?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07262788?
This trial is currently "Recruiting." It started on 2025-09-30. The estimated completion date is 2027-03.
Who is sponsoring NCT07262788?
NCT07262788 is sponsored by Steno Diabetes Center Copenhagen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07262788?
The trial aims to enroll 24 participants. The trial is currently recruiting and accepting new participants.
How is NCT07262788 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07262788?
The primary outcome measures are: Feasibility testing of diet adherence (Baseline, weeks 18, 24, 36, and 52.); Feasibility testing of exercise adherence (3 sessions pr. week, from week 13 to 52.); Feasibility testing of GP recruitment & safety procedures - quantitative assessment (Through study completion, an average of 52 weeks.); Feasibility testing of GP experiences and study procedures - qualitative assessment (Through study completion, an average of 52 weeks.); Feasibility testing of participant recruitment & retention (Through study completion, an average of 52 weeks.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07262788 being conducted?
This trial is being conducted at 1 site, including Herlev, Denmark (Denmark).
Where can I find official information about NCT07262788?
The official record for NCT07262788 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07262788. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07262788 testing in simple terms?
This study tests if a 12-month lifestyle program can help people with Type 2 Diabetes achieve and maintain remission. It is for adults recently diagnosed with Type 2 Diabetes who are overweight or obese and not on insulin.
Why is this trial significant?
This trial matters because it explores a non-drug approach to potentially reverse Type 2 Diabetes, addressing a significant need for effective remission strategies.
What are the potential risks of participating in NCT07262788?
Potential risks include fatigue, dizziness, or nutrient deficiencies during the initial very low-calorie diet phase. Some participants might experience changes in blood sugar levels that require careful monitoring. There's a risk of not achieving diabetes remission or regaining weight after the intervention. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07262788?
Ask your doctor if this lifestyle intervention is suitable for your specific health situation and diabetes management. Be prepared for a structured diet and exercise program, which may involve initial very low-calorie intake followed by specific meal plans and regular physical activity. Understand that the study involves regular visits and assessments to monitor your progress and safety throughout the 12 months. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07262788 signal from an investment perspective?
This feasibility study signals investor interest in non-pharmacological approaches for Type 2 Diabetes, a large market with a growing demand for remission-focused treatments. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves following a specific diet and exercise plan, with regular check-ins. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.