Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. (PREDIABRUN)
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|ClinicalTrials.gov Identifier: NCT04463160|
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Other: prevention program for prediabetes "Say No to Diabetes"||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the "Say No to Diabetes" Intervention.|
|Actual Study Start Date :||July 18, 2019|
|Estimated Primary Completion Date :||July 2026|
|Estimated Study Completion Date :||December 2026|
|Experimental: prevention program for prediabetes "Say No to Diabetes"||
Other: prevention program for prediabetes "Say No to Diabetes"
10 therapeutic education sessions
|No Intervention: No prevention program|
- The impact of the "Say No to Diabetes" intervention on the incidence of type 2 diabetes [ Time Frame: 2 years ]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)
- Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic [ Time Frame: 2 years ]Prediabetes : 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 sugar [ Time Frame: 2 years ]Normal 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 HGPO [ Time Frame: 2 years ]HbA1c assay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463160
|Contact: Samir MEDJANE||0262359750 ext +email@example.com|
|Centre Hospitalier Universitaire de la Réunion||Recruiting|
|Saint-Pierre, France, 97448|
|Contact: Samir MEDJANE firstname.lastname@example.org|
|Principal Investigator: Estelle NOBECOURT, PH|