TY - JOUR
T1 - Who will benefit from bariatric surgery for diabetes? A protocol for an observational cohort study
AU - Kenkre, Julia S.
AU - Ahmed, Ahmed R.
AU - Purkayastha, Sanjay
AU - Malallah, Khalefah
AU - Bloom, Stephen
AU - Blakemore, Alexandra I.
AU - Prevost, A. Toby
AU - Tan, Tricia
N1 - Funding Information:
JSK is funded by a National Institute for Health Research (NIHR) Doctoral Research Fellowship for this research project. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Funding Information:
Funding This work was supported by NIHR grant number (DRF-2017-10-042).
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/2/10
Y1 - 2021/2/10
N2 - Introduction Type 2 diabetes mellitus (T2DM) and obesity are pandemic diseases that lead to a great deal of morbidity and mortality. The most effective treatment for obesity and T2DM is bariatric or metabolic surgery; it can lead to long-term diabetes remission with 4 in 10 of those undergoing surgery having normal blood glucose on no medication 1 year postoperatively. However, surgery carries risks and, additionally, due to resource limitations, there is a restricted number of patients who can access this treatment. Moreover, not all those who undertake surgery respond equally well metabolically. The objective of the current research is to prospectively investigate predictors of T2DM response following metabolic surgery, including those directly involved in its aetiopathogenesis such as fat distribution and genetic variants. This will inform development of a clinically applicable model to help prioritise this therapy to those predicted to have remission. Methods and analysis A prospective multicentre observational cohort study of adult patients with T2DM and obesity undergoing Roux-en-Y gastric bypass surgery. Patients will be comprehensively assessed before surgery to determine their clinical, metabolic, psychological, genetic and fat distribution profiles. A multivariate logistic regression model will be used to assess the value of the factors derived from the preoperative assessment in terms of prediction of diabetes remission. Ethics and dissemination Formal ethics review was undertaken with a favourable opinion (UK HRA RES reference number 18/LO/0931). The dissemination plan is to present the results at conferences, in peer-reviewed journals as well as to lay media and to patient organisations. Trial registration details ClinicalTrials.gov, Identifier: NCT03842475.
AB - Introduction Type 2 diabetes mellitus (T2DM) and obesity are pandemic diseases that lead to a great deal of morbidity and mortality. The most effective treatment for obesity and T2DM is bariatric or metabolic surgery; it can lead to long-term diabetes remission with 4 in 10 of those undergoing surgery having normal blood glucose on no medication 1 year postoperatively. However, surgery carries risks and, additionally, due to resource limitations, there is a restricted number of patients who can access this treatment. Moreover, not all those who undertake surgery respond equally well metabolically. The objective of the current research is to prospectively investigate predictors of T2DM response following metabolic surgery, including those directly involved in its aetiopathogenesis such as fat distribution and genetic variants. This will inform development of a clinically applicable model to help prioritise this therapy to those predicted to have remission. Methods and analysis A prospective multicentre observational cohort study of adult patients with T2DM and obesity undergoing Roux-en-Y gastric bypass surgery. Patients will be comprehensively assessed before surgery to determine their clinical, metabolic, psychological, genetic and fat distribution profiles. A multivariate logistic regression model will be used to assess the value of the factors derived from the preoperative assessment in terms of prediction of diabetes remission. Ethics and dissemination Formal ethics review was undertaken with a favourable opinion (UK HRA RES reference number 18/LO/0931). The dissemination plan is to present the results at conferences, in peer-reviewed journals as well as to lay media and to patient organisations. Trial registration details ClinicalTrials.gov, Identifier: NCT03842475.
KW - adult surgery
KW - general diabetes
KW - nutrition & dietetics
UR - http://www.scopus.com/inward/record.url?scp=85101011483&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-042355
DO - 10.1136/bmjopen-2020-042355
M3 - Article
C2 - 33568372
AN - SCOPUS:85101011483
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - 042355
ER -
