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 |
| Protocol serial number | R0782 |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Funder | Diabetes Endowment Fund, University of Hull (UK) |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Observational prospective longitudinal study |
| Secondary study design | Other |
| Study type | Participant 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(s) |
To show that Roux-en-Y surgery significantly improves endothelial function. |
| Key secondary outcome measure(s) |
To illustrate that bariatric surgery improves fibrin clot structure and function. |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
HS Brocklehurst Building
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
