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

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prevention program for prediabetes "Say No to Diabetes"
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de la RéunionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prevention program for prediabetes "Say No to Diabetes"

No prevention program

Arm Description

Outcomes

Primary Outcome Measures

The impact of the "Say No to Diabetes" intervention on the incidence of type 2 diabetes
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

Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic
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
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
HbA1c assay

Full Information

First Posted
June 30, 2020
Last Updated
July 3, 2020
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT04463160
Brief Title
Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island.
Acronym
PREDIABRUN
Official Title
Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the "Say No to Diabetes" Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prevention program for prediabetes "Say No to Diabetes"
Arm Type
Experimental
Arm Title
No prevention program
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
prevention program for prediabetes "Say No to Diabetes"
Intervention Description
10 therapeutic education sessions
Primary Outcome Measure Information:
Title
The impact of the "Say No to Diabetes" intervention on the incidence of type 2 diabetes
Description
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic
Description
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)
Time Frame
2 years
Title
Number of patients return to normal blood sugar
Description
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).
Time Frame
2 years
Title
HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO
Description
HbA1c assay
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir MEDJANE
Phone
0262359750
Ext
+262
Email
samir.medjane@chu-reunion.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir MEDJANE
Email
samir.medjane@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Estelle NOBECOURT, PH

12. IPD Sharing Statement

Plan to Share IPD
No

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

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