Condition category
Digestive System
Date applied
12/07/2011
Date assigned
05/01/2012
Last edited
06/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Matthew Banks

ORCID ID

Contact details

University College London Hospital
250 Euston Road
London
NW1 2BU
United Kingdom
+44 20 7380 9419
matthew.banks@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v.2 06/01/2011

Study information

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

Acronym

Study hypothesis

The aim of this study is to investigate whether there is a connection between obesity and the development of Barrett's Oesophagus.

Ethics approval

East Central London Research Ethics Committee, 09/02/2011, ref: 10/H0721/83

Study design

Single centre non-randomised controlled trial

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 Barrett’s Oesophagus will be recruited from patients booked to have an OGD on a list dedicated to a Barrett’s 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 Barrett’s 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

Phase

Not Applicable

Drug names

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

01/05/2011

Overall trial end date

30/05/2013

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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

01/05/2011

Recruitment end date

30/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospital
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London Hospital [UCLH] (UK)

Sponsor details

c/o Dr Philip Diamond
Research and Development Department
Rosenheim Building
25 Grafton Way
London
WC1E 6DB
United Kingdom
+44 (0)20 7380 9833
philip.diamond@uclh.nhs.uk

Sponsor type

University/education

Website

http://www.uclh.org/

Funders

Funder type

Charity

Funder name

University College London Hospital (UCLH) Charities - Clinical Research and Development Committee (CRDC) (UK) ref: GCT/2011/MB-Po

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

01/03/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26671515

Publication citations

Additional files

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.