|- candidate number||10480|
|- NTR Number||NTR3119|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-okt-2011|
|- Secondary IDs||2011/040 METC AMC|
|- Public Title||Uitgebreide analyse van de stofwisseling van patiŽnten die bariatrische chirurgie ondergaan.|
|- Scientific Title||Extended metabolic phenotyping of subjects undergoing bariatric surgery.|
|- hypothesis||1. Adult subjects who are characterized by a high systemic inflammatory state as well as a high level of inflammation in adipose tissue will have the highest metabolic response to bariatric surgery, i.e. the greatest increase in insulin sensitivity, measured as HOMA-IR;|
2. Levels of circulating FFA are correlated with systemic inflammation as well as with the level of inflammation in adipose tissue;
3. The presence of hypertension, defined as > 130/80 mmHg, and insulin resistance, defined as HOMA-IR > 2.7, is associated with markers of systemic inflammation and oxidative stress;
4. The amount of EWL is correlated with pre-surgery weight as well as with eating pattern with restraint eaters having the greatest EWL.
|- Healt Condition(s) or Problem(s) studied||Metabolic syndrome, Obesity, Insulin resistance|
|- Inclusion criteria||1. Scheduled for malabsorptive bariatric surgery;|
2. Age 18-65 years;
3. Stable weight for 3 months prior to inclusion.
|- Exclusion criteria||1. Major bleeding disorder;|
2. Renal insufficiency (creatinine > 150 umol/L), liver enzymes > 3x ULN;
3. All medical conditions except for obesity related diseases and thyroid disorders;
4. Unable to read or speak the Dutch language.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||27-okt-2011|
|- planned closingdate||1-apr-2016|
|- Target number of participants||1200|
|- Primary outcome||1. To identify predictive variables correlated with percentage excess weight loss (EWL), reversal of metabolic complications of obesity, quality of life after bariatric surgery and postoperative complications (special focus on inflammatory pathways and eating behavior);|
2. To identify metabolic variables (using a metabolomics approach) in plasma and tissue (adipose tissue as well as liver) correlated with metabolic health c.q. markers of the metabolic syndrome.
|- Secondary outcome||1. To assess the prevalence of hypertension and metabolic complications of obesity in obese patients scheduled for bariatric surgery;|
2. To study the association of eating behavior with possible polymorphisms involved in appetite regulation and with markers of metabolic health.
|- Timepoints||1. Screening/inclusion;|
2. T=0: operation;
3. T=6 months: follow-up;
4. T=12 months: follow-up.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Murat Kilicarslan|
|- CONTACT for SCIENTIFIC QUERIES|| M.J.M. Serlie|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Background of the study:|
Bariatric surgery is the only proven treatment for obesity in the long term, however postoperative complications do occur. It is currently unknown which subgroup of patients wilt benefit the most in terms of weight loss and reversal of metabolic complications of obesity and which parameters wilt predict postoperative complications and treatment failure.
Objective of the study:
To identify predictive variables correlated with percentage excess weight loss, reversal of metabolic complications of obesity and quality of life and postoperative complications; to identify metabolic variables correlated with markers of the metabolic syndrome. To assess the prevalence of hypertension and metabolic complications of obesity in patients up for bariatric surgery. To study the association of eating behavior with possible polymorphisms in appetite regulation and with markers of metabolic health.
Prospective longitudinal cohort study.
Adult obese subjects (aged 18-65 years) scheduled for malabsorptive bariatric surgery in one of the participating centers.
Primary study parameters/outcome of the study:
Predictive value of pre-operative variables to weight loss expressed as percentage excess weight loss, reversal of metabolic complications of obesity, quality of life and postoperative complications; eating behavior and quality of life before and after bariatric surgery; pre-operative metabolic variables in plasma and tissue (adipose tissue and liver) correlated with metabolic health c.q. markers of the metabolic syndrome.
Secundary study parameters/outcome of the study:
Prevalence of hypertension and metabolic complications of obesity before and after bariatric surgery; association of eating behavior with polymorphisms involved in appetite regulation and markers of pre-operative metabolic health.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Blood and urine samples will be collected after an overnight fast four times: before, immediately prior to and 6 and 12 months after bariatric surgery. Biometrie data such as waist circumference, BMI and blood pressure will also be measured. Subjects will be asked to fill in questionnaires regarding eating behavior (Dutch Eating Behaviour Questionnaire) and quality of life (SF-36). During surgery biopsies will be taken from visceral and abdominal subcutaneous adipose tissue and the liver. The risks of bleeding from the biopsy sites during the bariatric surgery procedure are very small because the biopsy sites are completely visible to the surgeon and local hemostasis will be checked.
|- Main changes (audit trail)|
|- RECORD||26-okt-2011 - 3-nov-2011|