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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB Patients | Laparoscopic long limb roux-en-Y gastric bypass group. All consecutive patients eligible for bariatric surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic long limb roux-en-Y gastric bypass | Procedure | standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Homocysteine in µmol/l assessed by CMIA technique. | 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. | timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Weight in kg measured by a standard scale. | 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. | timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively |
| Folate in nmol/l assessed by ELCIA method. |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients eligible for bariatric surgery according to the american society of metabolic and bariatric surgery criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Prager, MD | Medical University of Vienna, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2011158 | Result | Clarke R, Daly L, Robinson K, Naughten E, Cahalane S, Fowler B, Graham I. Hyperhomocysteinemia: an independent risk factor for vascular disease. N Engl J Med. 1991 Apr 25;324(17):1149-55. doi: 10.1056/NEJM199104253241701. | |
| 17196442 | Result | Williams DB, Hagedorn JC, Lawson EH, Galanko JA, Safadi BY, Curet MJ, Morton JM. Gastric bypass reduces biochemical cardiac risk factors. Surg Obes Relat Dis. 2007 Jan-Feb;3(1):8-13. doi: 10.1016/j.soard.2006.10.003. Epub 2006 Dec 27. |
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There is no plan to share individual participant data to other researchers yet.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2018 | Mar 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D008659 | Metabolic Diseases |
| D005494 | Folic Acid Deficiency |
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Collection of blood samples during routine pre- and postoperative visits.
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. |
| 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. | 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. | 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. | Assessed conditions: events of myocardial infarction, stroke, deep vein thrombosis and peripheral artery disease which were not preexistent. | 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 |
| 20186576 | Result | Woodard GA, Peraza J, Bravo S, Toplosky L, Hernandez-Boussard T, Morton JM. One year improvements in cardiovascular risk factors: a comparative trial of laparoscopic Roux-en-Y gastric bypass vs. adjustable gastric banding. Obes Surg. 2010 May;20(5):578-82. doi: 10.1007/s11695-010-0088-0. Epub 2010 Feb 26. |
| 10022413 | Result | Borson-Chazot F, Harthe C, Teboul F, Labrousse F, Gaume C, Guadagnino L, Claustrat B, Berthezene F, Moulin P. Occurrence of hyperhomocysteinemia 1 year after gastroplasty for severe obesity. J Clin Endocrinol Metab. 1999 Feb;84(2):541-5. doi: 10.1210/jcem.84.2.5476. |
| 11410823 | Result | Dixon JB, Dixon ME, O'Brien PE. Elevated homocysteine levels with weight loss after Lap-Band surgery: higher folate and vitamin B12 levels required to maintain homocysteine level. Int J Obes Relat Metab Disord. 2001 Feb;25(2):219-27. doi: 10.1038/sj.ijo.0801474. |
| 25139582 | Result | Lapointe M, Poirier P, Martin J, Bastien M, Auclair A, Cianflone K. Omentin changes following bariatric surgery and predictive links with biomarkers for risk of cardiovascular disease. Cardiovasc Diabetol. 2014 Aug 21;13:124. doi: 10.1186/s12933-014-0124-9. |
| 11506296 | Result | Sheu WH, Wu HS, Wang CW, Wan CJ, Lee WJ. Elevated plasma homocysteine concentrations six months after gastroplasty in morbidly obese subjects. Intern Med. 2001 Jul;40(7):584-8. doi: 10.2169/internalmedicine.40.584. |
| 19487104 | Result | Toh SY, Zarshenas N, Jorgensen J. Prevalence of nutrient deficiencies in bariatric patients. Nutrition. 2009 Nov-Dec;25(11-12):1150-6. doi: 10.1016/j.nut.2009.03.012. Epub 2009 May 31. |
| 17658015 | Result | Gomez-Ambrosi J, Pastor C, Salvador J, Silva C, Rotellar F, Gil MJ, Catalan V, Rodriguez A, Cienfuegos JA, Fruhbeck G. Influence of waist circumference on the metabolic risk associated with impaired fasting glucose: effect of weight loss after gastric bypass. Obes Surg. 2007 May;17(5):585-91. doi: 10.1007/s11695-007-9101-7. |
| 20814760 | Result | Ledoux S, Coupaye M, Bogard C, Clerici C, Msika S. Determinants of hyperhomocysteinemia after gastric bypass surgery in obese subjects. Obes Surg. 2011 Jan;21(1):78-86. doi: 10.1007/s11695-010-0269-x. |
| 18830787 | Result | Sledzinski T, Goyke E, Smolenski RT, Sledzinski Z, Swierczynski J. Decrease in serum protein carbonyl groups concentration and maintained hyperhomocysteinemia in patients undergoing bariatric surgery. Obes Surg. 2009 Mar;19(3):321-6. doi: 10.1007/s11695-008-9691-8. Epub 2008 Oct 2. |
| 27683780 | Result | Tedesco AK, Biazotto R, Gebara TS, Cambi MP, Baretta GA. PRE- AND POSTOPERATIVE IN BARIATRIC SURGERY: SOME BIOCHEMICAL CHANGES. Arq Bras Cir Dig. 2016;29Suppl 1(Suppl 1):67-71. doi: 10.1590/0102-6720201600S10017. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |