Obesity, MorbidNCT03489538
Homocysteine After Laparoscopic Roux-enY Gastric Bypass
An observational study of Obesity, Morbid and Homocystine; Metabolic Disorder, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Morbid, Homocystine; Metabolic Disorder, Bariatric Surgery Candidate
- What is being tested?
- laparoscopic long limb roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 708 participants
- Where
- 1 siteAustria
- Study dates
- 9 Apr 2013to 11 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients eligible for bariatric surgery according to the american society of metabolic and bariatric surgery criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Homocysteine After Laparoscopic Roux-enY Gastric Bypass: a Comprehensive Evalutation in 708 Patients
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.
Read the 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.
- Conditions
- Obesity, Morbid, Homocystine; Metabolic Disorder, Bariatric Surgery Candidate, Folate Deficiency, Vitamin B 12 Deficiency
- Being tested
- laparoscopic long limb roux-en-Y gastric bypass
- Keywords
- bariatric surgery, gastric bypass, homocysteine, folate, vitamin b12
- Medical subject headings
- Obesity, Morbid, Metabolic Diseases, Folic Acid Deficiency, Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic long limb roux-en-Y gastric bypassProcedure or surgery
standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm)
| Study group | Role | What they receive |
|---|---|---|
| RYGB Patients | Laparoscopic long limb roux-en-Y gastric bypass group. All consecutive patients eligible for bariatric surgery. Receives: Procedure: laparoscopic long limb roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start9 Apr 2013
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Prager, Medical University of Vienna
- Investigators
- Gerhard Prager, MD, Principal investigator, Medical University of Vienna, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489538
- Sponsor's protocol ID
- EK1143
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers yet.
Publications
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.
PubMed 2011158Williams 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.
PubMed 17196442Woodard 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.
PubMed 20186576Borson-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.
PubMed 10022413Dixon 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.
PubMed 11410823Lapointe 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.
PubMed 25139582Sheu 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.
PubMed 11506296Toh 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.
PubMed 19487104Gomez-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.
PubMed 17658015Ledoux 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.
PubMed 20814760Sledzinski 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.
PubMed 18830787Tedesco 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.
PubMed 27683780
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homocysteine After Laparoscopic Roux-enY Gastric Bypass: a Comprehensive Evalutation in 708 Patients
- ClinicalTrials.gov ID
- NCT03489538
- Acronym / sponsor ID
- EK1143
- Conditions
- Obesity, Morbid, Homocystine; Metabolic Disorder, Bariatric Surgery Candidate, Folate Deficiency, Vitamin B 12 Deficiency
- Keywords
- bariatric surgery, gastric bypass, homocysteine, folate, vitamin b12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 9 Apr 2013 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RYGB Patients | – | Procedure: laparoscopic long limb roux-en-Y gastric bypassLaparoscopic long limb roux-en-Y gastric bypass group. All consecutive patients eligible for bariatric surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients eligible for bariatric surgery according to the american society of metabolic and bariatric surgery criteria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic long limb roux-en-Y gastric bypassstandard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm) | Procedure or surgery | RYGB Patients |
Primary outcome
Homocysteine in µmol/l assessed by CMIA technique.
Time frame: 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.
4 secondary outcomes
Weight in kg measured by a standard scale.
Time frame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
Folate in nmol/l assessed by ELCIA method.
Time frame: 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.
Time frame: 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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Results publication: PubMed 2011158Clarke 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.
- Results publication: PubMed 17196442Williams 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.
- Results publication: PubMed 20186576Woodard 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.
- Results publication: PubMed 10022413Borson-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.
- Results publication: PubMed 11410823Dixon 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.
- Results publication: PubMed 25139582Lapointe 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.
- Results publication: PubMed 11506296Sheu 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.
- Results publication: PubMed 19487104Toh 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.
- Results publication: PubMed 17658015Gomez-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.
- Results publication: PubMed 20814760Ledoux 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.
- Results publication: PubMed 18830787Sledzinski 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.
- Results publication: PubMed 27683780Tedesco 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Prager, MD principal investigator
Medical University of Vienna, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Homocystine; Metabolic Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homocysteine in µmol/l assessed by CMIA technique. (time frame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489538, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.