NCT07017127Recruiting
Remission of Type 2 Diabetes With Lifestyle Intervention
Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 8 Mar 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- University of Split, School of Medicine
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07017127
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 May 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- insulin therapy
Other illness
- heart failure (NYHA III, NYHA IV)
- chronic kidney disease and estimated glomerular filtration rate \<30 ml/min/1.73 m2
- heart attack or stroke in the past 1 year
- active malignant disease diagnosed in the past 1 year
- eating disorders
- food allergy
Lab values
- HbA1c \>12%
Other
- mobility restriction
- use of mobility aids
- TSH \>10 mU/L
- 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
- active treatment of proliferative diabetic retinopathy with anti-VEGF
- pregnancy or pregnancy planning
- substance abuse
- learning disabilities
- acute episode of severe depression
- current use of antipsychotics
Who the study is looking for
- type 2 diabetes diagnosis
- incident cases or diagnosed not more than 7 years ago
- body mass index of 27-45 kg/m²
Age in the registry: 20 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Split School of Medicine Coordinator of this site? Confirm its status | Split | Croatia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.