Remission of Type 2 Diabetes With Lifestyle Intervention
Recruiting · NCT07017127 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Split, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to achieve diabetes type 2 (DM2) remission using intensive lifestyle intervention. The main questions it aims to answer are: * Does intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) lead to DM2 remission (HbA1c\<6.5%, without medications) * Can intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) result to weight loss of \>15 kg * Does intensive lifestyle intervention result in any side effects (secondary outcome) Researchers will compare intensive lifestyle intervention to the usual clinical care (control group). Participants in the experimental group will: * eat Mediterranean diet with a caloric deficit * perform daily physical activity * increase their stress resilience with psychosocial support of the group * enroll weekly in individual and group counseling and workshops for 6 months, following with 1.5 years of follow-up
Who can take part
Inclusion criteria
- type 2 diabetes diagnosis
- incident cases or diagnosed not more than 7 years ago
- body mass index of 27-45 kg/m²
Exclusion criteria
- mobility restriction
- use of mobility aids
- insulin therapy
- HbA1c \>12%
- TSH \>10 mU/L
- heart failure (NYHA III, NYHA IV)
- use of obesity pharmacotherapy (orlistat, GLP-1 receptor agonists, GLP-1/GIP dual agonists) for less than 6 months
- weight loss greater than 5 kg in the last 6 months
- chronic kidney disease and estimated glomerular filtration rate \<30 ml/min/1.73 m2
- active treatment of proliferative diabetic retinopathy with anti-VEGF
- heart attack or stroke in the past 1 year
- active malignant disease diagnosed in the past 1 year
- eating disorders
- pregnancy or pregnancy planning
- substance abuse
- learning disabilities
- acute episode of severe depression
- current use of antipsychotics
- food allergy
Where it is running
1 location listed.
- University of Split School of Medicine - Split, Croatia