Diabetes Mellitus, Type 2NCT06969391
Representation of Diet in the Management of Type 2 Diabetes in Migrant Patients at CHSD
An observational study of Diabetes Mellitus, Type 2, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This observational and monocentric study aims to explore how migrant patients with type 2 diabetes perceive and represent food in the context of their diabetes care. Conducted at the Centre Hospitalier de Saint-Denis, the study investigates the cultural, social, and personal factors that influence dietary habits and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study participants will be selected from patients diagnosed with type 2 diabetes who are attending the Centre Hospitalier St Denis. Specifically, the target population includes: Adults aged 18 years or older. Migrants who have arrived in France within the past 7 years. Type 2 diabetes diagnosis for at least 3 months. French or English language proficiency to facilitate communication during interviews. The population will primarily consist of migrants from socioeconomically disadvantaged backgrounds, including those who may face barriers such as language differences, cultural challenges, and limited access to healthcare. Participants will have a range of cultural backgrounds, as the study aims to explore how migration and cultural factors influence their understanding and management of type 2 diabetes, particularly in relation to food and diet. This population is chosen to address the knowledge gap regarding how migrant populations perceive and integrate dietary advice in the
Who may be able to join
- Type 2 diabetic for at least 3 months
- Arrived in France less than 7 years ago
- Adult patient (age 18)
- Speaking French or English
Who cannot join
- Minor patient (age < 18 years)
- Type 1 diabetes
- Does not speak French or English
- Patient who has expressed opposition to the use of his data, or his refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier (CH) de Saint-Denis
Saint-Denis
COSSEC, +33142356140, coordination.rechercheclinique@ghtpdfr.fr
About this study
This observational and monocentric study aims to explore how migrant patients with type 2 diabetes perceive and represent food in the context of their diabetes care. Conducted at the Centre Hospitalier de Saint-Denis, the study investigates the cultural, social, and personal factors that influence dietary habits and how these perceptions affect the management of their condition. The goal is to improve the understanding of patient behaviors and support more culturally adapted care strategies.
- Conditions
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetic Migrants Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Representation of food in the care of diabetes in migrants Description
This measure will assess how migrants perceive and integrate food-related recommendations and dietary advice in the management of their type 2 diabetes. Through semi-structured interviews, the study will evaluate whether the food-related aspects of care are understood, accepted, and applied in practice by the migrant population, considering cultural and socio-economic factors.
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969391
- Sponsor's protocol ID
- 0049_ENDOCRINOLOGIE
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representation of Diet in the Management of Type 2 Diabetes in Migrant Patients at CHSD
- ClinicalTrials.gov ID
- NCT06969391
- Acronym / sponsor ID
- 0049_ENDOCRINOLOGIE
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational and monocentric study aims to explore how migrant patients with type 2 diabetes perceive and represent food in the context of their diabetes care. Conducted at the Centre Hospitalier de Saint-Denis, the study investigates the cultural, social, and personal factors that influence dietary habits and how these perceptions affect the management of their condition. The goal is to improve the understanding of patient behaviors and support more culturally adapted care strategies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetic Migrants Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants will be selected from patients diagnosed with type 2 diabetes who are attending the Centre Hospitalier St Denis. Specifically, the target population includes: Adults aged 18 years or older. Migrants who have arrived in France within the past 7 years. Type 2 diabetes diagnosis for at least 3 months. French or English language proficiency to facilitate communication during interviews. The population will primarily consist of migrants from socioeconomically disadvantaged backgrounds, including those who may face barriers such as language differences, cultural challenges, and limited access to healthcare. Participants will have a range of cultural backgrounds, as the study aims to explore how migration and cultural factors influence their understanding and management of type 2 diabetes, particularly in relation to food and diet. This population is chosen to address the knowledge gap regarding how migrant populations perceive and integrate dietary advice in the
Key inclusion criteria (4 listed)
- Type 2 diabetic for at least 3 months
- Arrived in France less than 7 years ago
- Adult patient (age 18)
- Speaking French or English
Key exclusion criteria (4 listed)
- Minor patient (age < 18 years)
- Type 1 diabetes
- Does not speak French or English
- Patient who has expressed opposition to the use of his data, or his refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Representation of food in the care of diabetes in migrants Description
Time frame: enrollment
This measure will assess how migrants perceive and integrate food-related recommendations and dietary advice in the management of their type 2 diabetes. Through semi-structured interviews, the study will evaluate whether the food-related aspects of care are understood, accepted, and applied in practice by the migrant population, considering cultural and socio-economic factors.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre Hospitalier (CH) de Saint-Denis
Saint-Denis, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Centre Hospitalier de Saint-Denis at 1 site in France.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Representation of food in the care of diabetes in migrants Description (time frame: enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.