Optimal non-drug lifestyle changes for people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This 12-month, two-arm feasibility trial will randomize adults with recent type 2 diabetes and BMI ≥27 to either a carbohydrate-rich diet with exercise or a carbohydrate-reduced diet with exercise. Participants may continue most oral diabetes medications and GLP-1 receptor agonists if their weight has been stable, while people on insulin are excluded. The intervention combines dietary composition changes, structured physical activity, and behavioral support and will track adherence, weight loss, glycemic control, and remission rates. Results will be used to refine recruitment, design, and delivery for a larger 24-month, 5-arm randomized trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Steno Diabetes Center Copenhagen
  Herlev, Denmark, Denmark Recruiting

Study contacts

• Principal investigator: Jonas Salling Quist Senior Researcher and Associate Professor, PhD — Steno Diabetes Center Copenhagen, University of Copenhagen - Department of Biomedical Sciences
• Study coordinator: Jonas Salling Quist Senior Researcher and Associate Professor, PhD
• Email: jonas.salling.quist@regionh.dk
• Phone: +45 26176064

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.