Bariatric Surgery Candidate, Folate Deficiency, Homocystine; Metabolic Disorder, Obesity, Morbid, Vitamin B 12 Deficiency
Conditions
Keywords
bariatric surgery, gastric bypass, homocysteine, folate, vitamin b12
Brief summary
Changes in homocysteine values after bariatric surgery remain controversially discussed. This is the first comprehensive summary to depict timeline changes in homocysteine levels following laparoscopic roux-en-Y gastric bypass.
Detailed description
Homocysteine is an independent risk factor for cardiovascular disease. Changes in homocysteine levels following bariatric surgery remain controversially discussed. 708 consecutive patients underwent laparoscopic roux-en-Y gastric bypass over a 6 year period. Throughout their routine follow-up, demographic data as well as homocysteine, folate and vitamin B12 were retrospectively collected at the timepoints: preoperatively, at 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, and 96 months postoperatively. In order to reveal clinical relevance of the results, patients were sent a special questionnaire accompanied by an informed consent form for participation and asked for cardiovascular disease events (myocardial infarction, stroke, deep venous thrombosis) or any other hospital stay after the surgery and cross checked with two region wide databases which account for approx. 80% of all hospital contacts in the region. Additionally, the database was networked with the statewide death registry in order to reveal deceased subjects and data about their demise through the beforementioned databases was collected.
Interventions
PROCEDURElaparoscopic long limb roux-en-Y gastric bypass
standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm)
Sponsors
Medical University of Vienna
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BMI \> 40kg/m2 or BMI \> 35 kg/m2 including relevant comorbidities * Age between 18 to 75 years * suitable for operation, consent * no contraindications for the operation
Exclusion criteria
* BMI \< 35 kg/m2 * age below 18 or above 75 years * not able to consent to the operation * severe medical conditions not applicable for general anaesthesia * non compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homocysteine in µmol/l assessed by CMIA technique. | timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively | Measured by Chemiluminescent microparticle immunoassay (CMIA) technique in µmol/l. Change of homocysteine over the timeframe at the timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight in kg measured by a standard scale. | timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively | Change of weight in kg over the timeframe at the timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively. |
| Folate in nmol/l assessed by ELCIA method. | timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively | ELCIA: electrochemiluminescent immunoassay Change of folate in nmol/l over the timeframe at the timepoints preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively. |
| Vitamin B12 in pmol/l assessed by CMIA technique. | timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively | Change of vitamin B12 in pmol/l over the timeframe at the timepoints preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively. |
| Number of cardiovascular events assessed by a questionnaire and cross checking with 2 state wide databases. | Through study attendance the specific date of the incident was assessed and assigned to the timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively | Assessed conditions: events of myocardial infarction, stroke, deep vein thrombosis and peripheral artery disease which were not preexistent. |
Countries
Austria
Outcome results
None listed