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

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.

Eligibility

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

Conditions2

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