Actively Recruiting
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes (ON LiMiT)
Led by Steno Diabetes Center Copenhagen · Updated on 2026-03-03
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Steno Diabetes Center Copenhagen
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to test the feasibility of a 12-month, two-group lifestyle intervention designed to induce and maintain remission of type 2 diabetes (T2D). The study focuses on adults recently diagnosed with T2D who are overweight or obese and not on insulin therapy. It explores different diet compositions combined with high-intensity exercise to find the best approach to support remission and improve metabolic health. The findings will guide a larger 24-month trial with more groups. Participants will first follow a very low-calorie diet (VLCD) for 12 weeks. Then they will be randomly assigned to one of two groups for the next phase: one group will transition to a carbohydrate-rich diet (50-55% carbs) combined with high-intensity exercise, and the other will switch to a carbohydrate-reduced diet (25-30% carbs) with the same exercise program. Both groups receive structured support, including meal boxes, supervised and unsupervised exercise sessions, and ongoing dietary guidance over 52 weeks. Throughout the study, participants will attend regular visits for assessments including diet and exercise adherence, blood tests, body measurements, and metabolic tests like the Mixed Meal Tolerance Test (MMTT). Researchers will monitor safety, recruitment, retention, and participant experiences. Data on blood sugar control, weight changes, body composition, cardiovascular health, and quality of life will also be collected. The total study duration is about 52 weeks with a follow-up interview three months after completion.
CONDITIONS
Brief Title
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes treated with lifestyle changes or oral anti-diabetic medications
- HbA1c between 36 and 86 mmol/mol
- Type 2 diabetes duration of 6 years or less
- Body mass index (BMI) of 27 kg/m2 or higher
- Body weight stable with changes of 3 kg or less in the last 3 months
- Adults aged 18 to 75 years
You will not qualify if you...
- Insulin treatment within 6 months prior to screening
- Heart failure with ejection fraction 40% or less and treated with SGLT-2 inhibitors
- Cardiovascular disease requiring incretin-based therapy or SGLT-2 inhibitors
- Kidney disease with eGFR less than 60 ml/min/1.73m2 or albuminuria for at least 3 months and treated with SGLT-2 inhibitors
- Physical conditions preventing participation in physical activity
- Dietary restrictions or allergies that prevent adherence to study diets
- Inability to comply with trial procedures or interventions
- Alcohol or drug abuse
- Planned or current pregnancy, fertility treatment, or no contraception during reproductive age
- Unstable psychiatric illness that impedes participation
- Diagnosis of binge eating disorder
- Participation in other clinical trials involving lifestyle or medication interventions
- HbA1c of 60 mmol/mol or higher with use of 2 or more anti-diabetic drugs and positive GAD65 antibodies or low stimulated C-peptide levels (<800 pM)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants follow a very-low-calorie diet for 12 weeks to induce weight loss.
Regular visits for monitoring and support during the diet phase
Duration - 6 weeks
Participants transition over 6 weeks from the VLCD to either a carbohydrate-rich or carbohydrate-reduced diet combined with a high-intensity exercise program including supervised and unsupervised sessions.
Weekly visits including two supervised 1-hour exercise sessions and one unsupervised 1-hour session per week
Duration - 34 weeks
Participants receive ongoing support for their assigned diet and exercise regimen while preparing their own meals and attending exercise sessions.
Weekly visits with two supervised and one unsupervised exercise sessions per week
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Copenhagen
Herlev, Denmark, Denmark, 2730
Actively Recruiting
Research Team
J
Jonas Salling Quist Senior Researcher and Associate Professor, PhD
A
Anne-Ditte Termannsen Project Manager, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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