Plain English Summary
Dr Matthew Banks
University College London Hospital
250 Euston Road
+44 20 7380 9419
Prevalence of metabolic obesity in patients with Barrett's Oesophagus and its potential role in carcinogenesis: a single centre non-randomised controlled trial
The aim of this study is to investigate whether there is a connection between obesity and the development of Barrett's Oesophagus.
East Central London Research Ethics Committee, 09/02/2011, ref: 10/H0721/83
Single centre non-randomised controlled trial
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Barrett's Oesophagus and metabolic obesity
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.
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
A total of 460 subjects will be recruited: 230 with known Barrett's Oesophagus and 230 without Barrett's Oesophagus
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University College London Hospital
University College London Hospital [UCLH] (UK)
c/o Dr Philip Diamond
Research and Development Department
25 Grafton Way
+44 (0)20 7380 9833
University College London Hospital (UCLH) Charities - Clinical Research and Development Committee (CRDC) (UK) ref: GCT/2011/MB-Po
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26671515