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

• Sponsor: Azienda Ospedaliero-Universitaria Careggi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06131411
• Collaborator: Azienda Ospedaliera Universitaria Renato Dulbecco (Other), AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia (Other), Istituto Nazionale per la promozione della salute delle popolazioni Migranti e per il contrasto delle malattie della Povertà (INMP) (Other)
• Enrollment: 200
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 17.7
• Patients Per Site: 50
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: Health promotion; Other: Usual care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies
• Actual Study Start Date: Nov 7, 2023
• Anticipated Primary Completion Date: Mar 31, 2025
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.
Placebo Comparator: Control Usual care	Other: Usual care; Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.

Outcome Measures

Primary Outcome Measures

1. Glycated haemoglobin (HbA1c) [from baseline to follow-up at month 12]

   Change in glycated haemoglobin (HbA1c)

Secondary Outcome Measures

1. Systolic Blood Pressure [from baseline to follow-up at month 12]

   Change in Systolic Blood Pressure

2. Diastolic Blood Pressure [from baseline to follow-up at month 12]

   Change in Diastolic Blood Pressure

3. Total Cholesterol [from baseline to follow-up at month 12]

   Change in Total Cholesterol

4. LDL Cholesterol [from baseline to follow-up at month 12]

   Change in LDL Cholesterol

5. HDL Cholesterol [from baseline to follow-up at month 12]

   Change in HDL Cholesterol

6. Triglycerides [from baseline to follow-up at month 12]

   Change in triglycerides

7. Body Mass Index (BMI) [from baseline to follow-up at month 12]

   Change in Body Mass Index (BMI)

8. Waist circumference [from baseline to follow-up at month 12]

   Change in Waist circumference

9. Physical activity [from baseline to follow-up at month 12]

   Change in compliance with World Health Organization recommended exercise goals

10. Adherence to Mediterranean Diet [from baseline to follow-up at month 12]

    Change in Adherence to Mediterranean Diet

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera Universitaria Renato Dulbecco	Catanzaro		Italy	88100
2	Azienda Ospedaliera-Universitaria Careggi	Florence		Italy	50134
3	AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia	Reggio Emilia		Italy	42122
4	Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)	Rome		Italy	00153

Sponsors and Collaborators

• Azienda Ospedaliero-Universitaria Careggi
• 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 ospedaliera universitaria Careggi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Azienda Ospedaliero-Universitaria Careggi
• ClinicalTrials.gov Identifier: NCT06131411
• Other Study ID Numbers: DIABETHIC
• First Posted: Nov 14, 2023
• Last Update Posted: Nov 14, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Azienda Ospedaliero-Universitaria Careggi: migrants; health promotion; ethnic minorities; cardiovascular diseases; obesity; hypertension; diabetes
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Metabolic Diseases

Study Results

No Results Posted as of Nov 14, 2023