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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal therapeutic procedures
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
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.
Background summary
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 will benefit the most in terms of weight loss and reversal
of metabolic complications of obesity and which parameters will predict
postoperative complications and treatment failure.
Study objective
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.
Study design
Prospective longitudinal cohort study
Study burden and risks
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.
Biometric 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.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Scheduled for malabsorptive bariatric surgery in one of the participating centers
Aged 18-65 years
Stable weight for 3 months prior to inclusion
Exclusion criteria
Major bleeding disorder
Renal insufficiency (creatinine > 150 umol/L), liver enzymes > 3x ULN
Unable to read or speak the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35026.018.11 |