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Completed

NCT Number: NCT03489538

Homocysteine After Laparoscopic Roux-enY Gastric Bypass

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.

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Key information

Conditions

Obesity, Morbid Avitaminosis Bariatric Surgery Candidate Body Weight Deficiency Diseases Folate Deficiency Folic Acid Deficiency Homocystine; Metabolic Disorder Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    Assessed conditions: events of myocardial infarction, stroke, deep vein thrombosis and peripheral artery disease which were not preexistent.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2018
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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