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

Diabetes Mellitus, Type 2 Clinical Trial

— DIABETHIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131411
• Other study ID #: DIABETHIC
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Pietro A Modesti, MD, PhD
• Phone: 055 7949376
• Email: pa.modesti[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the efficacy of the co-created, culture-sensitive intervention to promote healthy diet, physical activity, and to improve compliance to therapeutic protocols in immigrants with type 2 diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Diseases

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

Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated haemoglobin (HbA1c)	Change in glycated haemoglobin (HbA1c)	from baseline to follow-up at month 12
Secondary	Systolic Blood Pressure	Change in Systolic Blood Pressure	from baseline to follow-up at month 12
Secondary	Diastolic Blood Pressure	Change in Diastolic Blood Pressure	from baseline to follow-up at month 12
Secondary	Total Cholesterol	Change in Total Cholesterol	from baseline to follow-up at month 12
Secondary	LDL Cholesterol	Change in LDL Cholesterol	from baseline to follow-up at month 12
Secondary	HDL Cholesterol	Change in HDL Cholesterol	from baseline to follow-up at month 12
Secondary	Triglycerides	Change in triglycerides	from baseline to follow-up at month 12
Secondary	Body Mass Index (BMI)	Change in Body Mass Index (BMI)	from baseline to follow-up at month 12
Secondary	Waist circumference	Change in Waist circumference	from baseline to follow-up at month 12
Secondary	Physical activity	Change in compliance with World Health Organization recommended exercise goals	from baseline to follow-up at month 12
Secondary	Adherence to Mediterranean Diet	Change in Adherence to Mediterranean Diet	from baseline to follow-up at month 12