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

NCT ID: NCT04463160

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2026-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

prevention program for prediabetes "Say No to Diabetes"

Group Type: EXPERIMENTAL

prevention program for prediabetes "Say No to Diabetes"

Intervention Type: OTHER

10 therapeutic education sessions

No prevention program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

prevention program for prediabetes "Say No to Diabetes"

10 therapeutic education sessions

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Samir MEDJANE

Role: CONTACT

samir.medjane@chu-reunion.fr

0262359750 ext. +262

Facility Contacts

Samir MEDJANE

Role: primary

samir.medjane@chu-reunion.fr

References

Anthony N, Bruneau L, Leruste S, Franco JM, Domercq A, Kowalczyk C, Nobecourt E, Marimoutou C. Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol. BMJ Open. 2022 Nov 21;12(11):e062520. doi: 10.1136/bmjopen-2022-062520.

Reference Type: DERIVED

PMID: 36410808 (View on PubMed)

Other Identifiers

2018-A03106-49

Identifier Type: OTHER

Identifier Source: secondary_id

2018/CHU/06

Identifier Type: -

Identifier Source: org_study_id