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

NCT04463160 | Recruiting

• 2 other identifiers: 2018/CHU/062018-A03106-49
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Secondary Outcomes (3)

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

  2 years

• Number of patients return to normal blood sugar

  2 years

• HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO

  2 years

Study Arms (2)

prevention program for prediabetes "Say No to Diabetes"

EXPERIMENTAL

Other: prevention program for prediabetes "Say No to Diabetes"

No prevention program

NO INTERVENTION

Interventions

prevention program for prediabetes "Say No to Diabetes" OTHER

10 therapeutic education sessions

prevention program for prediabetes "Say No to Diabetes"

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People likely to leave Reunion within 2 years
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, 97448, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36410808 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Samir MEDJANE

CONTACT

0262359750; samir.medjane@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 9, 2020
• Study Start: July 18, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)