The effect of Roux-en-Y bariatric surgery on early and late cardiovascular risk markers in patients with obesity
| ISRCTN | ISRCTN21400062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21400062 |
| Secondary identifying numbers | R0782 |
- Submission date
- 27/04/2009
- Registration date
- 13/05/2009
- Last edited
- 17/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephen Atkin
Scientific
Scientific
HS Brocklehurst Building
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Observational prospective longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | Bariatric surgery - CVR |
| Study objectives | To demonstrate the effects of Roux-en-Y bariatric surgery on both early and late manifestations of cardiovascular disease. |
| Ethics approval(s) | Hull and East Riding Local Research Ethics Committee, approved on 12/03/2009 (ref: 09/H1304/3). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 14/04/2009 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key exclusion criteria | Patients not wishing disclosure to their GP's. |
| Date of first enrolment | 14/04/2009 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
HS Brocklehurst Building
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
University/education
Diabetes Endowment Fund, University of Hull (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No |
