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Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)

INTRODUCTION: Despite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains...

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Autores principales: Gulsin, Gaurav Singh, Brady, Emer M, Swarbrick, Daniel J, Athithan, Lavanya, Henson, Joseph, Baldry, Emma, McAdam, John, Marsh, Anna-Marie, Parke, Kelly S, Wormleighton, Joanne V, Levelt, Eylem, Yates, Thomas, Bodicoat, Danielle, Khunti, Kamlesh, Davies, Melanie J, McCann, Gerry P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6475184/
https://www.ncbi.nlm.nih.gov/pubmed/30928925
http://dx.doi.org/10.1136/bmjopen-2018-023207
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author Gulsin, Gaurav Singh
Brady, Emer M
Swarbrick, Daniel J
Athithan, Lavanya
Henson, Joseph
Baldry, Emma
McAdam, John
Marsh, Anna-Marie
Parke, Kelly S
Wormleighton, Joanne V
Levelt, Eylem
Yates, Thomas
Bodicoat, Danielle
Khunti, Kamlesh
Davies, Melanie J
McCann, Gerry P
author_facet Gulsin, Gaurav Singh
Brady, Emer M
Swarbrick, Daniel J
Athithan, Lavanya
Henson, Joseph
Baldry, Emma
McAdam, John
Marsh, Anna-Marie
Parke, Kelly S
Wormleighton, Joanne V
Levelt, Eylem
Yates, Thomas
Bodicoat, Danielle
Khunti, Kamlesh
Davies, Melanie J
McCann, Gerry P
author_sort Gulsin, Gaurav Singh
collection PubMed
description INTRODUCTION: Despite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains to be established. METHODS AND ANALYSIS: Prospective, randomised, open-label, blind endpoint trial. The primary aim of the study is to determine if diastolic function can be improved by either a meal replacement plan or a supervised exercise programme, compared with guideline-directed care. A total of 90 obese participants with T2D (aged 18–65 years), diabetes duration <12 years and not on insulin treatment will be randomised to either guideline-directed clinical care with lifestyle coaching, a low-energy meal replacement diet (average ≈810 kcal/day) or a supervised exercise programme for 12 weeks. Participants undergo glycometabolic profiling, cardiopulmonary exercise testing, echocardiography and MRI scanning to assesses cardiac structure and function and dual-energy X-ray absorptiometry scanning for body composition. Key secondary aims are to assess the effects of the interventions on glycaemic control and insulin resistance, exercise capacity, blood pressure, changes in body composition and association of favourable cardiac remodelling with improvements in weight loss, exercise capacity and glycometabolic control. ETHICS AND DISSEMINATION: The study has full ethical approval, and data collection was completed in August 2018. The study results will be submitted for publication within 6 months of completion. TRIAL REGISTRATION NUMBER: NCT02590822; Pre-results.
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spelling pubmed-64751842019-05-07 Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study) Gulsin, Gaurav Singh Brady, Emer M Swarbrick, Daniel J Athithan, Lavanya Henson, Joseph Baldry, Emma McAdam, John Marsh, Anna-Marie Parke, Kelly S Wormleighton, Joanne V Levelt, Eylem Yates, Thomas Bodicoat, Danielle Khunti, Kamlesh Davies, Melanie J McCann, Gerry P BMJ Open Cardiovascular Medicine INTRODUCTION: Despite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains to be established. METHODS AND ANALYSIS: Prospective, randomised, open-label, blind endpoint trial. The primary aim of the study is to determine if diastolic function can be improved by either a meal replacement plan or a supervised exercise programme, compared with guideline-directed care. A total of 90 obese participants with T2D (aged 18–65 years), diabetes duration <12 years and not on insulin treatment will be randomised to either guideline-directed clinical care with lifestyle coaching, a low-energy meal replacement diet (average ≈810 kcal/day) or a supervised exercise programme for 12 weeks. Participants undergo glycometabolic profiling, cardiopulmonary exercise testing, echocardiography and MRI scanning to assesses cardiac structure and function and dual-energy X-ray absorptiometry scanning for body composition. Key secondary aims are to assess the effects of the interventions on glycaemic control and insulin resistance, exercise capacity, blood pressure, changes in body composition and association of favourable cardiac remodelling with improvements in weight loss, exercise capacity and glycometabolic control. ETHICS AND DISSEMINATION: The study has full ethical approval, and data collection was completed in August 2018. The study results will be submitted for publication within 6 months of completion. TRIAL REGISTRATION NUMBER: NCT02590822; Pre-results. BMJ Publishing Group 2019-03-30 /pmc/articles/PMC6475184/ /pubmed/30928925 http://dx.doi.org/10.1136/bmjopen-2018-023207 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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/.
spellingShingle Cardiovascular Medicine
Gulsin, Gaurav Singh
Brady, Emer M
Swarbrick, Daniel J
Athithan, Lavanya
Henson, Joseph
Baldry, Emma
McAdam, John
Marsh, Anna-Marie
Parke, Kelly S
Wormleighton, Joanne V
Levelt, Eylem
Yates, Thomas
Bodicoat, Danielle
Khunti, Kamlesh
Davies, Melanie J
McCann, Gerry P
Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
title Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
title_full Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
title_fullStr Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
title_full_unstemmed Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
title_short Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
title_sort rationale, design and study protocol of the randomised controlled trial: diabetes interventional assessment of slimming or training to lessen inconspicuous cardiovascular dysfunction (the diastolic study)
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6475184/
https://www.ncbi.nlm.nih.gov/pubmed/30928925
http://dx.doi.org/10.1136/bmjopen-2018-023207
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