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"Different diets in different diabetes" - diete diverse per diversi diabetici

NCT ID NCT07887477

Sponsor: University of Bologna Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

101 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • U.O.C. Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, BO, 40138, Italy

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