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Remission of Type 2 Diabetes With Lifestyle Intervention

RECRUITINGN/ASponsored by University of Split, School of Medicine
Actively Recruiting
PhaseN/A
SponsorUniversity of Split, School of Medicine
Started2025-05-01
Est. completion2027-06-01
Eligibility
Age20 Years – 69 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 20 Years – 69 YearsHealthy volunteers accepted
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

Conditions4

DiabetesDiabetes Mellitus, Type 2Obese DiabeticsWeight Loss

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