NCT06473584

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

April 2, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 19, 2024

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Estimating the prevalence of glycaemic abnormalities (diabetes and pre-diabetes) in Réunion

    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

Study Arms (1)

Detection of glycaemic anomalies

OTHER
Diagnostic Test: Diabetes detection

Interventions

Diabetes detectionDIAGNOSTIC_TEST

Fasting glycemia on blood sample

Detection of glycaemic anomalies

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU La Réunion

Saint-Denis, Reunion

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Catherine MARIMOUTOU, MD, PhD

    CHU La Réunion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

April 2, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations