Prevalence of metabolic obesity in patients with Barrett's Oesophagus and its potential role in carcinogenesis

ISRCTN	ISRCTN99001055
DOI	https://doi.org/10.1186/ISRCTN99001055
Protocol serial number	v.2 06/01/2011
Sponsor	University College London Hospital [UCLH] (UK)
Funder	University College London Hospital (UCLH) Charities - Clinical Research and Development Committee (CRDC) (UK) ref: GCT/2011/MB-Po

Submission date: 12/07/2011
Registration date: 05/01/2012
Last edited: 06/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-obesity-people-barretts-oesophagus

Contact information

Dr Matthew Banks
Scientific

University College London Hospital
250 Euston Road
London
NW1 2BU
United Kingdom

Phone	+44 20 7380 9419
Email	matthew.banks@uclh.nhs.uk

Study information

Primary study design	Observational
Study design	Single centre non-randomised controlled trial
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Prevalence of metabolic obesity in patients with Barrett's Oesophagus and its potential role in carcinogenesis: a single centre non-randomised controlled trial
Study objectives	The aim of this study is to investigate whether there is a connection between obesity and the development of Barrett's Oesophagus.
Ethics approval(s)	East Central London Research Ethics Committee, 09/02/2011, ref: 10/H0721/83
Health condition(s) or problem(s) studied	Barrett's Oesophagus and metabolic obesity
Intervention	The study will be divided in 2 phases (total duration 12 months): Phase 1: Recruitment, collection of data, endoscopy (OGD) biopsy and histology, blood tests (duration 8 months). 1. Subjects with known Barretts Oesophagus will be recruited from patients booked to have an OGD on a list dedicated to a Barretts oesophagus surveillance programme undertaken at University College Hospital, UK. 2. The control group will be recruited from patients booked to have an elective OGD for other gastrointestinal indications (negative at endoscopy for Barretts Oesophagus). Phase 2: Gata collection and analysis (duration 4 months) 1. Data will be entered into a database 2. Data analysis The prevalence of obesity, overweight and metabolic obesity will be determined. Anthropometric measurements and body composition (bioimpedance) and biochemical indices of metabolic syndrome will be measured. In those subjects with Barrett's Oesophagus histological presence of metaplasia/dysplasia will also be assessed.
Intervention type	Other
Primary outcome measure(s)	Prevalence of overweight, obesity, and metabolic obesity in subjects with Barrett's Oesophagus as compared to subjects without Barrett's Oesophagus (standardised for age and sex). All the measures will be done only once at baseline, when patients attend their endoscopy test as part of their clinical management. No follow-up is required.
Key secondary outcome measure(s)	1. The characteristics of body composition, metabolic parameters and serum level of adiponectin/leptin in obese, overweight and metabolic obese subjects compared to those of normal weight. 2. The prevalence of abdominal obesity (in obese and overweight subjects) and metabolic obesity in subjects with dysplastic Barrett's oesophagus compared to those without dysplasia. All the measures will be done only once at baseline, when patients attend their endoscopy test as part of their clinical management. No follow-up is required.
Completion date	30/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	460
Key inclusion criteria	1. Able to understand the nature and requirements of the study and to provide written informed consent 2. Aged 18 - 79 years 3. Booked to undergo routine oesophagogastroduodenoscopy
Key exclusion criteria	1. Weight loss of more than 10% in the last year 2. Known decompensated liver disease 3. Coeliac disease 4. Inflammatory bowel disease 5. Previous upper gastrointestinal tract surgery 6. Known malignancy or undergoing treatment for previously resected malignancy 7. Inability to provide informed consent
Date of first enrolment	01/05/2011
Date of final enrolment	30/04/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London Hospital

London
NW1 2BU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/06/2016: The recruitment end date have been updated from 30/04/2012 to 30/05/2013. Additionally, the availability of the participant level data has been added.
11/05/2016: Publication reference added.