AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - 75 YearsAllSteno Diabetes Center Copenhagen
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • CH-rich diet with exercise
  • CH-reduced diet with exercise
📍

Where

1 site
Steno Diabetes Center Copenhagen
Herlev, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy