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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

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.


Condition or disease Intervention/treatment Phase
Diabetes Other: prevention program for prediabetes "Say No to Diabetes" Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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).

  3. HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO [ Time Frame: 2 years ]
    HbA1c assay



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Samir MEDJANE 0262359750 ext +262 samir.medjane@chu-reunion.fr

Locations
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France
Centre Hospitalier Universitaire de la Réunion Recruiting
Saint-Pierre, France, 97448
Contact: Samir MEDJANE       samir.medjane@chu-reunion.fr   
Principal Investigator: Estelle NOBECOURT, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04463160    
Other Study ID Numbers: 2018/CHU/06
2018-A03106-49 ( Other Identifier: ID-RCB )
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases