A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes
Recruiting · NCT07262788 · Interventional (participants receive a specific treatment) · Lead sponsor: Steno Diabetes Center Copenhagen
View the official record on ClinicalTrials.gov →Interventions studied
CH-reduced diet with exerciseCH-rich diet with exercise
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Steno Diabetes Center Copenhagen - Herlev, Denmark, Denmark