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

Last updated: January 27, 2026
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Overall Status: Completed

Phase

N/A

Condition

Obesity

Diabetes Mellitus, Type 2

Stress

Treatment

Usual care

Health promotion

Clinical Study ID

NCT06131411
DIABETHIC
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Immigrant status: Self-identification of being born in High migration pressurecountries 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

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 notfeasible, as judged by clinical staff members

Study Design

Total Participants: 202
Treatment Group(s): 2
Primary Treatment: Usual care
Phase:
Study Start date:
November 07, 2023
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro 2525059, Catanzaro 88100
    Italy

    Site Not Available

  • Azienda Ospedaliera-Universitaria Careggi

    Florence 3176959, Florence 50134
    Italy

    Site Not Available

  • AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia

    Reggio Emilia 3169522, Reggio Emilia 42122
    Italy

    Site Not Available

  • Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)

    Rome 3169070, Rome 00153
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, 88100
    Italy

    Site Not Available

  • Azienda Ospedaliera-Universitaria Careggi

    Florence, 50134
    Italy

    Site Not Available

  • AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia

    Reggio Emilia, 42122
    Italy

    Site Not Available

  • Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)

    Rome, 00153
    Italy

    Site Not Available

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