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Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol

INTRODUCTION: Improved knowledge of prediabetic subjects’ profile and their risk of developing type 2 diabetes mellitus (T2DM) would enhance secondary prevention. The primary objective is to describe factors associated with incident T2DM in subjects with pre-diabetes diagnosed in primary care. METHO...

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Autores principales: Anthony, Norah, Bruneau, Léa, Leruste, Sebastien, Franco, Jean-Marc, Domercq, Alain, Kowalczyk, Christine, Nobecourt, Estelle, Marimoutou, C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9680172/
https://www.ncbi.nlm.nih.gov/pubmed/36410808
http://dx.doi.org/10.1136/bmjopen-2022-062520
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author Anthony, Norah
Bruneau, Léa
Leruste, Sebastien
Franco, Jean-Marc
Domercq, Alain
Kowalczyk, Christine
Nobecourt, Estelle
Marimoutou, C
author_facet Anthony, Norah
Bruneau, Léa
Leruste, Sebastien
Franco, Jean-Marc
Domercq, Alain
Kowalczyk, Christine
Nobecourt, Estelle
Marimoutou, C
author_sort Anthony, Norah
collection PubMed
description INTRODUCTION: Improved knowledge of prediabetic subjects’ profile and their risk of developing type 2 diabetes mellitus (T2DM) would enhance secondary prevention. The primary objective is to describe factors associated with incident T2DM in subjects with pre-diabetes diagnosed in primary care. METHODS AND ANALYSIS: The study is based on Reunion Island, a French overseas region that experiences a particularly high disease burden of T2DM. This is an observational, non-randomised prospective cohort study conducted in primary care in which private general practitioner (GP) investigators recruit participants with pre-diabetes from their practices regardless of the initial motive for consultation. Pre-diabetes is defined by WHO criteria, that is, fasting plasma glucose between 1.10 g/L and 1.25 g/L and/or plasma glucose 2 hours after ingestion of 75 g of glucose (2-hour post load plasma glucose) between 1.40 g/L and 1.99 g/L. The design is based on an annual follow-up by the GP (according to French National Health Authority recommendations) with collection of clinical and laboratory data and specific lifestyle questionnaires answered by telephone at three time points: inclusion, and at 2-year and 5-year follow-up visits. Follow-up clinical and laboratory data are collected by the investigating GP as part of the study, and study-specific laboratory collections (serum, DNA and urine) will be obtained 2 and 5 years after inclusion. The primary outcome is transition to T2DM. ETHICS AND DISSEMINATION: This protocol has been approved by the research ethics committee of Saint Etienne (CPP Saint Etienne reference number: 2019–03). Enrolment began in August 2019. Results will be disseminated in at least three papers published in peer-reviewed medical journals, one oral communication and a large-scale communication to the local population and healthcare policymakers. TRIAL REGISTRATION NUMBER: NCT04463160 and ID-RCB 2018-A03106-49.
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spelling pubmed-96801722022-11-23 Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol Anthony, Norah Bruneau, Léa Leruste, Sebastien Franco, Jean-Marc Domercq, Alain Kowalczyk, Christine Nobecourt, Estelle Marimoutou, C BMJ Open Diabetes and Endocrinology INTRODUCTION: Improved knowledge of prediabetic subjects’ profile and their risk of developing type 2 diabetes mellitus (T2DM) would enhance secondary prevention. The primary objective is to describe factors associated with incident T2DM in subjects with pre-diabetes diagnosed in primary care. METHODS AND ANALYSIS: The study is based on Reunion Island, a French overseas region that experiences a particularly high disease burden of T2DM. This is an observational, non-randomised prospective cohort study conducted in primary care in which private general practitioner (GP) investigators recruit participants with pre-diabetes from their practices regardless of the initial motive for consultation. Pre-diabetes is defined by WHO criteria, that is, fasting plasma glucose between 1.10 g/L and 1.25 g/L and/or plasma glucose 2 hours after ingestion of 75 g of glucose (2-hour post load plasma glucose) between 1.40 g/L and 1.99 g/L. The design is based on an annual follow-up by the GP (according to French National Health Authority recommendations) with collection of clinical and laboratory data and specific lifestyle questionnaires answered by telephone at three time points: inclusion, and at 2-year and 5-year follow-up visits. Follow-up clinical and laboratory data are collected by the investigating GP as part of the study, and study-specific laboratory collections (serum, DNA and urine) will be obtained 2 and 5 years after inclusion. The primary outcome is transition to T2DM. ETHICS AND DISSEMINATION: This protocol has been approved by the research ethics committee of Saint Etienne (CPP Saint Etienne reference number: 2019–03). Enrolment began in August 2019. Results will be disseminated in at least three papers published in peer-reviewed medical journals, one oral communication and a large-scale communication to the local population and healthcare policymakers. TRIAL REGISTRATION NUMBER: NCT04463160 and ID-RCB 2018-A03106-49. BMJ Publishing Group 2022-11-21 /pmc/articles/PMC9680172/ /pubmed/36410808 http://dx.doi.org/10.1136/bmjopen-2022-062520 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Diabetes and Endocrinology
Anthony, Norah
Bruneau, Léa
Leruste, Sebastien
Franco, Jean-Marc
Domercq, Alain
Kowalczyk, Christine
Nobecourt, Estelle
Marimoutou, C
Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol
title Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol
title_full Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol
title_fullStr Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol
title_full_unstemmed Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol
title_short Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol
title_sort diabetes incidence in subjects with prediabetes from reunion island: the prediabrun observational cohort study protocol
topic Diabetes and Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9680172/
https://www.ncbi.nlm.nih.gov/pubmed/36410808
http://dx.doi.org/10.1136/bmjopen-2022-062520
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