Cargando…
Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol
INTRODUCTION: Effective treatments are lacking for idiopathic intracranial hypertension (IIH), a condition characterised by raised intracranial pressure (ICP) and papilloedema, and found primarily in obese women. Weight loss and lowering body mass index (BMI) have been shown to lower ICP and improve...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5623580/ https://www.ncbi.nlm.nih.gov/pubmed/28963303 http://dx.doi.org/10.1136/bmjopen-2017-017426 |
_version_ | 1783268121516179456 |
---|---|
author | Ottridge, Ryan Mollan, Susan P Botfield, Hannah Frew, Emma Ives, Natalie J Matthews, Tim Mitchell, James Rick, Caroline Singhal, Rishi Woolley, Rebecca Sinclair, Alexandra J |
author_facet | Ottridge, Ryan Mollan, Susan P Botfield, Hannah Frew, Emma Ives, Natalie J Matthews, Tim Mitchell, James Rick, Caroline Singhal, Rishi Woolley, Rebecca Sinclair, Alexandra J |
author_sort | Ottridge, Ryan |
collection | PubMed |
description | INTRODUCTION: Effective treatments are lacking for idiopathic intracranial hypertension (IIH), a condition characterised by raised intracranial pressure (ICP) and papilloedema, and found primarily in obese women. Weight loss and lowering body mass index (BMI) have been shown to lower ICP and improve symptoms in IIH; however, weight loss is typically not maintained, meaning IIH symptoms return. The Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) will assess whether bariatric surgery is an effective long-term treatment for patients with IIH with a BMI over 35 kg/m(2). The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35 kg/m(2) and a qualifying comorbidity; currently IIH does not qualify as a comorbidity. METHODS AND ANALYSIS: IIH:WT is a multicentre, open-label, randomised controlled clinical trial of 64 participants with active IIH and a BMI over 35 kg/m(2). Participants will be randomised in a 1:1 ratio to bariatric surgery or a dietary weight loss programme and followed up for 5 years. The primary outcome measure is ICP at 12 months. Secondary outcome measures include ICP at 24 and 60 months, and IIH symptoms, visual function, papilloedema, headache, quality of life and cost-effectiveness at 12, 24 and 60 months. TRIAL REGISTRATION NUMBER: IIH:WT is registered as ISRCTN40152829 and on ClinicalTrials.gov as NCT02124486 and is in the pre-results stage. |
format | Online Article Text |
id | pubmed-5623580 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-56235802017-10-10 Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol Ottridge, Ryan Mollan, Susan P Botfield, Hannah Frew, Emma Ives, Natalie J Matthews, Tim Mitchell, James Rick, Caroline Singhal, Rishi Woolley, Rebecca Sinclair, Alexandra J BMJ Open Neurology INTRODUCTION: Effective treatments are lacking for idiopathic intracranial hypertension (IIH), a condition characterised by raised intracranial pressure (ICP) and papilloedema, and found primarily in obese women. Weight loss and lowering body mass index (BMI) have been shown to lower ICP and improve symptoms in IIH; however, weight loss is typically not maintained, meaning IIH symptoms return. The Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) will assess whether bariatric surgery is an effective long-term treatment for patients with IIH with a BMI over 35 kg/m(2). The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35 kg/m(2) and a qualifying comorbidity; currently IIH does not qualify as a comorbidity. METHODS AND ANALYSIS: IIH:WT is a multicentre, open-label, randomised controlled clinical trial of 64 participants with active IIH and a BMI over 35 kg/m(2). Participants will be randomised in a 1:1 ratio to bariatric surgery or a dietary weight loss programme and followed up for 5 years. The primary outcome measure is ICP at 12 months. Secondary outcome measures include ICP at 24 and 60 months, and IIH symptoms, visual function, papilloedema, headache, quality of life and cost-effectiveness at 12, 24 and 60 months. TRIAL REGISTRATION NUMBER: IIH:WT is registered as ISRCTN40152829 and on ClinicalTrials.gov as NCT02124486 and is in the pre-results stage. BMJ Publishing Group 2017-09-27 /pmc/articles/PMC5623580/ /pubmed/28963303 http://dx.doi.org/10.1136/bmjopen-2017-017426 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Neurology Ottridge, Ryan Mollan, Susan P Botfield, Hannah Frew, Emma Ives, Natalie J Matthews, Tim Mitchell, James Rick, Caroline Singhal, Rishi Woolley, Rebecca Sinclair, Alexandra J Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol |
title | Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol |
title_full | Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol |
title_fullStr | Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol |
title_full_unstemmed | Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol |
title_short | Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol |
title_sort | randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the idiopathic intracranial hypertension weight trial (iih:wt) protocol |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5623580/ https://www.ncbi.nlm.nih.gov/pubmed/28963303 http://dx.doi.org/10.1136/bmjopen-2017-017426 |
work_keys_str_mv | AT ottridgeryan randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT mollansusanp randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT botfieldhannah randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT frewemma randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT ivesnataliej randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT matthewstim randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT mitchelljames randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT rickcaroline randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT singhalrishi randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT woolleyrebecca randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol AT sinclairalexandraj randomisedcontrolledtrialofbariatricsurgeryversusacommunityweightlossprogrammeforthesustainedtreatmentofidiopathicintracranialhypertensiontheidiopathicintracranialhypertensionweighttrialiihwtprotocol |