Homocysteine After Laparoscopic Roux-enY Gastric Bypass

Bariatric Surgery Candidate Clinical Trial

Official title:

Homocysteine After Laparoscopic Roux-enY Gastric Bypass: a Comprehensive Evalutation in 708 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489538
• Other study ID #: EK1143
• Status: Completed
• First received: February 22, 2018
• Last updated: March 29, 2018
• Start date: April 9, 2013
• Est. completion date: September 11, 2017

Study information

• Verified date: March 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: September 11, 2017
• Est. primary completion date: September 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Folate Deficiency
• Folic Acid Deficiency
• Homocystine; Metabolic Disorder
• Metabolic Diseases
• Obesity, Morbid
• Vitamin B 12 Deficiency

Intervention

Procedure:
• laparoscopic long limb roux-en-Y gastric bypass
standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm)

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (12)

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. — View 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. — View 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. — View Citation

Gómez-Ambrosi J, Pastor C, Salvador J, Silva C, Rotellar F, Gil MJ, Catalán V, Rodríguez A, Cienfuegos JA, Frühbeck G. Influence of waist circumference on the metabolic risk associated with impaired fasting glucose: effect of weight loss after gastric byp — View 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- — View 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. — View 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. — View 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/s11695-0 — View 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. English, Portuguese. — View 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. — View 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. Epub 2006 Dec 27. — View 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 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Folate in nmol/l assessed by ELCIA method.	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
Secondary	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
Secondary	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