Clinical trial NCT03489538: Homocysteine After Laparoscopic Roux-enY Gastric Bypass
Official title: Homocysteine After Laparoscopic Roux-enY Gastric Bypass: a Comprehensive Evalutation in 708 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Homocystine; Metabolic Disorder
Bariatric Surgery Candidate
Folate Deficiency
Vitamin B 12 Deficiency
Keywords: bariatric surgery
gastric bypass
homocysteine
folate
vitamin b12
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients eligible for bariatric surgery according to the american society of metabolic and bariatric surgery criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Homocysteine in µmol/l assessed by CMIA technique.
timeFrame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
Secondary outcomes:
measure: Weight in kg measured by a standard scale.
timeFrame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
measure: Folate in nmol/l assessed by ELCIA method.
timeFrame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
measure: Vitamin B12 in pmol/l assessed by CMIA technique.
timeFrame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
measure: Number of cardiovascular events assessed by a questionnaire and cross checking with 2 state wide databases.
timeFrame: 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
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Surgery
name: Gerhard Prager, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.