Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2009
Date assigned
13/05/2009
Last edited
17/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

HS Brocklehurst Building
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R0782

Study information

Scientific title

The effect of Roux-en-Y bariatric surgery on early and late cardiovascular risk markers in patients with obesity: an observational prospective study

Acronym

Bariatric surgery - CVR

Study hypothesis

To demonstrate the effects of Roux-en-Y bariatric surgery on both early and late manifestations of cardiovascular disease.

Ethics approval

Hull and East Riding Local Research Ethics Committee, approved on 12/03/2009 (ref: 09/H1304/3).

Study design

Observational prospective longitudinal study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Obesity

Intervention

Patients will be seen before surgery and then at 3 monthly intervals for 12 months after surgery. At each visit fasting bloods will be taken to determine insulin resistance along with fibrin structure and function. Endothelial function will be examined using Endo-PAT2000®.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To show that Roux-en-Y surgery significantly improves endothelial function.

Secondary outcome measures

To illustrate that bariatric surgery improves fibrin clot structure and function.

Overall trial start date

14/04/2009

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, over age of 16 years
2. Body Mass Index greater than 40 kg/m^2, or greater than 35 kg/m^2 with comorbidity
3. To have Roux-en-Y bariatric surgery
4. Able to give informed consent
5. Consent to inform their GP's regarding their participation in the study
6. No changes to medication in last 3 months
7. Smokers can be included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Patients not wishing disclosure to their GP's.

Recruitment start date

14/04/2009

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HS Brocklehurst Building
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom

Sponsor type

Government

Website

http://www.hey.nhs.uk

Funders

Funder type

University/education

Funder name

Diabetes Endowment Fund, University of Hull (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24198061

Publication citations

Additional files

Editorial Notes