An observational study in Obesity, Morbid, Homocystine; Metabolic Disorder and Bariatric Surgery Candidate, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Medical University of Vienna · Observational
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's enrollment of 708 is above the median of 80 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients eligible for bariatric surgery according to the american society of metabolic and bariatric surgery criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm)
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.
Time frame: timepoints: preoperatively, 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, and 96 months postoperatively
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.
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.
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.
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.
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.
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.
Assessed conditions: events of myocardial infarction, stroke, deep vein thrombosis and peripheral artery disease which were not preexistent.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to share individual participant data to other researchers yet.
Ran from Apr 2013 to primary completion in Sep 2017, 53 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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