- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473584
Study of the Prevalence of Diabetes and Pre-diabetes in Réunion Island (PREVADIABRUN)
In view of the new priority given to diabetes in Réunion and the implementation of an ambitious plan to combat the disease at regional level, which includes the identification and management of pre-diabetes, the need for up-to-date data on the extent of these 2 diseases (diabetes and pre-diabetes) has become essential.
These two diseases have known risk factors: age, overweight, obesity, high waist circumference, family history, hypertension, eating habits and physical activity, all of which form part of a risk score for developing diabetes: the Findrisk recommended by the Haute Autorité de Santé for identifying people at risk of diabetes. Given the specific population characteristics of Réunion compared with Finland, where this score has been validated, it would seem important to be able to measure these risk indicators in the population as a function of carbohydrate status in order to check that the proposed thresholds are appropriate for the population of Réunion.
Finally, cardiovascular risk has been described as early as the pre-diabetes stage. Given the young age of onset of diabetes in Réunion and the high proportion of diagnoses of diabetes made following the occurrence of a cardiovascular complication, the study of the prognosis of carbohydrate status on the occurrence of complications using the social security information system will be offered on a voluntary basis to study subjects (via a probabilistic social security link).
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Catherine MARIMOUTOU, MD, PhD
- Phone Number: +262 (0)262 90 50 50
- Email: catherine.marimoutou@chu-reunion.fr
Study Contact Backup
- Name: Florence LEFEBVRE D'HELLENCOURT
- Phone Number: +262 262 75 34 71
- Email: florence.lefebvre-dhellencourt@chu-reunion.fr
Study Locations
-
-
-
Saint-Denis, Reunion
- Recruiting
- CHU La Réunion
-
Contact:
- Catherine MARIMOUTOU, MD
- Phone Number: 262+ 262 90 50 27
- Email: catherine.marimoutou@chu-reunion.fr
-
Contact:
- Laetitia BERLY, PhD
- Email: promotion.drci@chu-reunion.fr
-
Principal Investigator:
- Catherine MARIMOUTOU, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have lived in Réunion island for at least one year
- Be aged between 18 and 75
- Affiliated to or benefiting from a social security scheme
- Free, informed and signed consent
Exclusion Criteria:
- No main residence on the island or fixed address for at least one year on the island
- Participation in experimental research
- Pregnant women
- Adults under guardianship or legal protection
- Not understanding French
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Detection of glycaemic anomalies
|
Fasting glycemia on blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimating the prevalence of glycaemic abnormalities (diabetes and pre-diabetes) in Réunion
Time Frame: Day 1
|
Measurement of fasting blood glucose and blood glucose 2 hours after ingesting 75g of glucose (HGPO test) according to Haute Autorite de Sante (HAS) recommendations used in France for diagnosing diabetes and pre-diabetes in people with unknown diabetes
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Catherine MARIMOUTOU, MD, PhD, CHU La Réunion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/CHU/42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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