Actively Recruiting
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes
Led by Steno Diabetes Center Copenhagen · Updated on 2026-03-03
24
Participants Needed
1
Research Sites
73 weeks
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
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
Official 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 including metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, or incretin-based medication
- 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 over the past 3 months
- Use of GLP-1 receptor agonists allowed if weight has been stable for at least 3 months prior to inclusion
You will not qualify if you...
- Insulin treatment within 6 months prior to screening (any type)
- Heart failure with ejection fraction 40% or less and treated with SGLT-2 inhibitors (current or planned)
- Cardiovascular disease including previous heart attack or stroke and prescribed incretin-based therapy and/or SGLT-2 inhibitors
- Kidney disease with eGFR less than 60 ml/min/1.73m2 and/or albuminuria of 30 mg/g or more for at least 3 months and treated with SGLT-2 inhibitors (current or planned)
- Physical conditions preventing participation in physical activity during the intervention
- Dietary restrictions or allergies preventing adherence to dietary interventions
- Inability to comply with trial procedures or interventions
- Alcohol or drug abuse
- Planned or current pregnancy, fertility treatment, or lack of contraception during reproductive age
- Unstable psychiatric disease that impedes participation
- Diagnosis of binge eating disorder
- Participation in other clinical trials involving lifestyle or pharmaceutical interventions
- If HbA1c is 60 mmol/mol or higher, use of two or more anti-diabetic drugs, and positive GAD65 and/or stimulated C-peptide less than 800 pM
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Anne-Ditte Termannsen Project Manager, PhD
CONTACT
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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