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Active Not Recruiting
NCT07887477
Different Diets in Different Diabetes - 4DI PLAN'EAT Pilot Study
Conditions: Type 2 Diabetes
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 101
Sponsor: University of Bologna
Location: U.O.C. Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna BO
Summary
The goal of this clinical trial is to learn whether a diet adapted to a person's cultural background, combined with a supervised physical activity programme, improves blood sugar control better than standard dietary advice in adults with type 2 diabetes. Participants come from four cultural backgrounds (Italian, Eastern European, North African, and South Asian) and live in Italy.
The main questions it aims to answer are:
* Does a culturally adapted Mediterranean diet combined with structured physical activity lower glycated haemoglobin (HbA1c) more than standard dietary advice?
* Does it reduce body weight, body mass index and waist circumference more than standard dietary advice?
Researchers will compare participants who receive the culturally adapted diet and the supervised walking programme with participants who receive standard dietary and behavioural advice, to see whether the adapted approach improves blood sugar control and body measurements more. Participants in both groups continue to receive their diabetes medication, adjusted as needed according to clinical guidelines.
Participants will:
* Attend medical visits at the start of the study and after 3, 6 and 12 months, where body weight, waist circumference, blood pressure and heart rate are measured and blood test results are reviewed;
* Meet a dietitian at the start of the study and after 3, 6 and 12 months;
* Complete questionnaires on perceived stress, sleep quality, mood and general health at each medical visit;
* Provide a finger-prick dried blood spot sample and a saliva sample at the beginning and end of each medical visit;
* If they choose to be assigned to the culturally adapted group, follow a personalised diet built around traditional dishes from their country of origin and take part in supervised group walks at least once a week for 12 months.
Eligibility Criteria
Inclusion Criteria:
* Age between 18 and 70 years at the time of signing the informed consent
* Belonging to one of the following ethnic groups: Italian, Eastern European, North African, or from the Indian subcontinent (India, Pakistan, Bangladesh, Sri Lanka)
* Diagnosis of type 2 diabetes mellitus
* Understanding of the Italian or English language
Exclusion Criteria:
* Type 1 diabetes mellitus
* Inability or unwillingness to participate in a structured physical activity program
* Active malignancy
* Chronic kidney disease (GFR \< 30 ml/min), heart failure (NYHA class 3 or 4), or hepatic failure
* Previous bariatric surgery
* Adherence to a weight-loss diet in the 3 months preceding the study
* Use of illicit or abused substances in the 3 months preceding the study
Source: ClinicalTrials.gov (NCT07887477). StuddyBuddy aggregates publicly available trial information.