Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies (DIABETHIC)

January 27, 2026 updated by: Azienda Ospedaliero-Universitaria Careggi
The purpose of this clinical trial is to learn if intervention on health behavior can promote diabetes care and improve compliance to therapeutic protocols in ethnic minorities with type 2 diabetes. To answer this question, researchers will compare the effectiveness of co-created, culture-sensitive intervention to that of a usual-care approach to promote diabetes care 12 months after enrollment in first-generation immigrants with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes mellitus has an unequal impact globally, with 80% of cases occurring in low- and middle-income countries. In particular, social determinants of health, such as education, employment, and living conditions, play a significant role in the unequal impact of diabetes. On the other hand, cultural aspects such as education on healthy behaviors, diet, adherence to drug therapy, self-monitoring of blood glucose, and physical activity, are essential for effective diabetes management. Finally, beliefs about the disease, communication difficulties, limited educational backgrounds, and the inability to understand educational materials and read food labels due to language barriers can pose obstacles to achieving adequate disease awareness and control among ethnic minorities. Large randomized clinical trials conducted over the past decade have examined the effectiveness of behavioral interventions to address these influences among diverse ethnic minorities. These studies, mainly conducted on specific ethnic groups living in the US such as Afro-American and Hispanic populations, reported improvements in glycosylated hemoglobin A1c control at 3- and at 6-months post intervention compared with control groups who received 'usual care', being sustained to a lesser extent at 12- and 24-months post intervention. In Europe, where diabetes disproportionately affects adult populations from ethnic minorities, with higher disease risk and complication and mortality rates compared to European host populations, studies on culturally sensitive diabetes self-management education and support are limited, and their effectiveness remains uncertain. The multicenter randomized clinical trial (DiabEthic trial) was therefore designed to compare the effectiveness of culture-sensitive intervention to that of a usual-care approach to promote diabetes care and to improve compliance to therapeutic protocols in first-generation immigrants with type 2 diabetes. To best transfer this experience into clinical practice, personalized cultural approaches to type 2 diabetes were developed with the support of representatives of ethnic communities living in Italy and the participation of specific cultural mediators. Unlike previous studies, this multicenter study focuses on the diversely represented ethnic communities in different parts of Italy.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Catanzaro
      • Catanzaro, Catanzaro, Italy, 88100
        • Azienda Ospedaliera Universitaria Renato Dulbecco
    • Florence
      • Florence, Florence, Italy, 50134
        • Azienda Ospedaliera-Universitaria Careggi
    • Reggio Emilia
      • Reggio Emilia, Reggio Emilia, Italy, 42122
        • AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia
    • Rome
      • Rome, Rome, Italy, 00153
        • Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Immigrant status: Self-identification of being born in High migration pressure countries from parents born in high migration pressure countries
  • Age ≥ 18 years
  • Type 2 diabetes newly diagnosed or with HbA1c > 8% in the last assessment within 24 months before the visit

Exclusion Criteria:

  • Patients who will not provide the informed consent
  • Patients with HbA1c ≤ 8% in the last assessment within 24 months before the visit
  • Severe psychiatric disorders
  • Pregnant women
  • Critical illness
  • Impaired cognitive or physical ability that could make the intervention not feasible, as judged by clinical staff members

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Usual care
Other: Usual care
Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.
Experimental: Intervention
Health promotion intervention
Other: Health promotion
Co-created culture-tailored intervention of health promotion aimed to increase healthy diet, physical activity and compliance with treatment protocols for diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated haemoglobin (HbA1c)
Time Frame: from baseline to follow-up at month 12
Change in glycated haemoglobin (HbA1c)
from baseline to follow-up at month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: from baseline to follow-up at month 12
Change in Systolic Blood Pressure
from baseline to follow-up at month 12
Diastolic Blood Pressure
Time Frame: from baseline to follow-up at month 12
Change in Diastolic Blood Pressure
from baseline to follow-up at month 12
Total Cholesterol
Time Frame: from baseline to follow-up at month 12
Change in Total Cholesterol
from baseline to follow-up at month 12
LDL Cholesterol
Time Frame: from baseline to follow-up at month 12
Change in LDL Cholesterol
from baseline to follow-up at month 12
HDL Cholesterol
Time Frame: from baseline to follow-up at month 12
Change in HDL Cholesterol
from baseline to follow-up at month 12
Triglycerides
Time Frame: from baseline to follow-up at month 12
Change in triglycerides
from baseline to follow-up at month 12
Body Mass Index (BMI)
Time Frame: from baseline to follow-up at month 12
Change in Body Mass Index (BMI)
from baseline to follow-up at month 12
Waist circumference
Time Frame: from baseline to follow-up at month 12
Change in Waist circumference
from baseline to follow-up at month 12
Physical activity
Time Frame: from baseline to follow-up at month 12
Change in compliance with World Health Organization recommended exercise goals
from baseline to follow-up at month 12
Adherence to Mediterranean Diet
Time Frame: from baseline to follow-up at month 12
Change in Adherence to Mediterranean Diet
from baseline to follow-up at month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Collaborators

Azienda Ospedaliera Universitaria Renato Dulbecco
AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia
Istituto Nazionale per la promozione della salute delle popolazioni Migranti e per il contrasto delle malattie della Povertà (INMP)

Investigators

  • Principal Investigator: Pietro A Modesti, MD, PhD, Azienda Ospedaliero-Universitaria Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIABETHIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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