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Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island.

Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the Say No to Diabetes Intervention.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04463160
Acronym
PREDIABRUN
Enrollment
2000
Registered
2020-07-09
Start date
2019-07-18
Completion date
2026-12-31
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

The management of diabetes and its complications in Reunion island is one of the priority areas of health. Indeed, the impact of diabetes on the health of the Reunion island population is major: the prevalence of diabetes treated in Reunion island is the highest in France (10% of the population), and gestational diabetes is found in 10% of pregnancies. Reunionese diabetics develop severe complications, in particular cardiovascular (strokes, myocardial infarction). This results in 3 times higher mortality linked to diabetes on Reunion Island, in particular among those under 65 years of age. Despite all the screening and prevention programs put in place, the weight of diabetic disease continues to increase in our island, and this is more accelerated than in the other French departments with 4,300 new cases of diabetes / year, 95% of which type 2 diabetics (T2D). The presentation of type 2 diabetic patients in Reunion island also differs from the Metropolis with subjects more often female (56%), thinner and younger at the discovery of diabetes. These data highlight the need to better understand the factors underlying the diabetes epidemic in Reunion island. The rise in blood sugar until the onset of diabetes is a continuous phenomenon reflecting the progressive suffering of the organs used to maintain carbohydrate homeostasis. Thus, we talk about fasting hyperglycemia when the fasting blood sugar is between 1.10 and 1.25 g / L (6.1-6.9 mmol / l) and glucose intolerance when the blood sugar 2 hours after taking 75 g of glucose is between 1.40 and 1.99 g / L (7.8-11.0 mmol / l). Subjects with fasting hyperglycemia or glucose intolerance constitute the target population at very high risk of developing diabetes (up to 70% of these subjects). They have an increased risk of developing diabetes at 1 year multiplied by 5 to 10 compared to normoglycemic subjects, hence the name prediabetic subjects. This great variability in the risk of developing diabetes highlights the presence of associated risk / protective factors which it is important to find in order to adapt the monitoring and management. It is important in Reunion island, in view of the specificities presented by our population, to understand the pre-diabetes / diabetes transition and the risk and protective factors.

Interventions

OTHERprevention program for prediabetes Say No to Diabetes

10 therapeutic education sessions

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Subject aged 25 to 70 with pre-diabetes defined by fasting blood sugar between 1.10 and 1.25 g / l (6.1 and 6.9 mmol / l) or blood sugar between 1.40 and 1.99 g / l (7.8 and 11.0 mmol / l) 2 hours after taking 75g of glucose (HGPO test), dating from less than 3 months. * Consulting one of the general practitioners involved in the study, whatever the initial reason for the consultation * able to answer a telephone survey questionnaire * who have never been diagnosed or treated for diabetes with the exception of gestational diabetes * Person affiliated or beneficiary of a social security scheme. * Free, informed and written consent signed

Exclusion criteria

* People likely to leave Reunion within 2 years * Persons placed under guardianship, curators, safeguard of justice, person participating in another research including an exclusion period still in progress. * Person with severely impaired physical and / or psychological health, who, according to the investigator, may affect the compliance of the study participant. * Pregnancy in progress

Design outcomes

Primary

MeasureTime frameDescription
The impact of the Say No to Diabetes intervention on the incidence of type 2 diabetes2 yearsDiabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)

Secondary

MeasureTime frameDescription
Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic2 yearsPrediabetes : fasting blood sugar is between 1.10 and 1.25 g / l (6.1 and 6.9 mmol / l) or a blood sugar level is between 1.40 and 1.99 g / l (7.8 and 11 0.0 mmol / l) 2 hours after taking 75g of glucose (HGPO test) Diabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)
Number of patients return to normal blood sugar2 yearsNormal blood sugar : fasting blood glucose \<1.10 g / l (6.1mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO \<1.40g / l (7.8 mmol / l).
HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO2 yearsHbA1c assay

Countries

France

Contacts

Primary ContactSamir MEDJANE
samir.medjane@chu-reunion.fr0262359750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026