Homocysteine After Laparoscopic Roux-enY Gastric Bypass

NCT03489538 | Completed

• 1 other identifier: EK1143
• Study Type: observational
• Target: 708
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Homocystine; Metabolic Disorder; Bariatric Surgery Candidate; Folate Deficiency; Vitamin B 12 Deficiency

Keywords

bariatric surgery; gastric bypass; homocysteine; folate; vitamin b12

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Weight in kg measured by a standard scale.

  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

• 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

• 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

Study Arms (1)

RYGB Patients

Laparoscopic long limb roux-en-Y gastric bypass group. All consecutive patients eligible for bariatric surgery.

Procedure: laparoscopic long limb roux-en-Y gastric bypass

Interventions

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)

RYGB Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (12)

• 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.

  PMID: 2011158 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.

  PMID: 17196442 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.

  PMID: 20186576 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.

  PMID: 10022413 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.

  PMID: 11410823 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.

  PMID: 25139582 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.

  PMID: 11506296 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.

  PMID: 19487104 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.

  PMID: 17658015 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.

  PMID: 20814760 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.

  PMID: 18830787 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.

  PMID: 27683780 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of blood samples during routine pre- and postoperative visits.

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Diseases; Folic Acid Deficiency; Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition

Study Officials

• Gerhard Prager, MD

  Medical University of Vienna, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, MD

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: April 5, 2018
• Study Start: April 9, 2013
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)