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Diabetes Mellitus, Type 2DIABETHICNCT06131411

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

A study testing Health promotion in people with Diabetes Mellitus, Type 2, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Health promotion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
4 sitesItaly
Study dates
7 Nov 2023to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, Catanzaro, 88100

  • Azienda Ospedaliera-Universitaria Careggi

    Florence, Florence, 50134

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

    Reggio Emilia, Reggio Emilia, 42122

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

    Rome, Rome, 00153

Other trials in Italy

About this study

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.

Read the 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.

Being tested
Health promotion, Usual care
Keywords
health promotion, ethnic minorities, cardiovascular diseases, obesity, hypertension, Migrant health, Ambulatory care-sensitive conditions, Diabetes Mellitus, Type 2
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Obesity, Hypertension, Ambulatory Care Sensitive Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health promotionOther

    Co-created culture-tailored intervention of health promotion aimed to increase healthy diet, physical activity and compliance with treatment protocols for diabetes.

  • Usual careOther

    Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.

Study groups in NCT06131411
Study groupRoleWhat they receive
InterventionExperimentalHealth promotion intervention
Receives: Other: Health promotion
ControlPlacebo comparatorUsual care
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated haemoglobin (HbA1c)

    Change in glycated haemoglobin (HbA1c)

    Measured: from baseline to follow-up at month 12

Secondary outcomes (10)

  1. Systolic Blood Pressure

    Change in Systolic Blood Pressure

    Measured: from baseline to follow-up at month 12

  2. Diastolic Blood Pressure

    Change in Diastolic Blood Pressure

    Measured: from baseline to follow-up at month 12

  3. Total Cholesterol

    Change in Total Cholesterol

    Measured: from baseline to follow-up at month 12

  4. LDL Cholesterol

    Change in LDL Cholesterol

    Measured: from baseline to follow-up at month 12

  5. HDL Cholesterol

    Change in HDL Cholesterol

    Measured: from baseline to follow-up at month 12

  6. Triglycerides

    Change in triglycerides

    Measured: from baseline to follow-up at month 12

  7. Body Mass Index (BMI)

    Change in Body Mass Index (BMI)

    Measured: from baseline to follow-up at month 12

  8. Waist circumference

    Change in Waist circumference

    Measured: from baseline to follow-up at month 12

  9. Physical activity

    Change in compliance with World Health Organization recommended exercise goals

    Measured: from baseline to follow-up at month 12

  10. Adherence to Mediterranean Diet

    Change in Adherence to Mediterranean Diet

    Measured: from baseline to follow-up at month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start7 Nov 2023
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131411
Sponsor's protocol ID
DIABETHIC
Acronym
DIABETHIC
Status last verified
Jan 2026
First submitted
9 Nov 2023
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pellegrino A, Bonvicini L, Petrelli A, Perticone M, Baccari C, Boddi M, Bononi F, Calabrese M, Rossi PG, Manicardi E, Pierconti S, Vacirca I, Venturelli F, Modesti PA; DIABETHIC Working Group. Efficacy of co-created, culturally-sensitive intervention for type 2 diabetes self-management education in immigrants in Italy: The DiabEthic randomized clinical trial. Diabetes Res Clin Pract. 2026 Sep;239:113464. doi: 10.1016/j.diabres.2026.113464. Epub 2026 Jul 28.

    PubMed 42520979

  • Bonvicini L, Venturelli F, Bononi F, Balestra GL, Iorio G, Ghirotto L, Petrelli A, Pierconti S, Laurendi G, Perticone M, Pellegrino A, Boddi M, Modesti PA, Giorgi Rossi P; DIABETHIC Working Group. A randomized trial to evaluate a complex, co-created, culture-sensitive intervention to promote healthy lifestyles and compliance to therapy in immigrants with type 2 diabetes: A protocol of a multicenter Italian study. PLoS One. 2025 Feb 24;20(2):e0317994. doi: 10.1371/journal.pone.0317994. eCollection 2025.

    PubMed 39992940

Questions about this trial

What is this clinical trial studying?

A study testing Health promotion in people with Diabetes Mellitus, Type 2, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated haemoglobin (HbA1c) (time frame: from baseline to follow-up at month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131411, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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