Patients qualified for bariatric surgery MedDRA version: 17.1 Level: LLT Classification code 10068900 Term: Bariatric surgery System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Omega-3 fatty acids
Product Name: Omega 3-acid-ethyl esters 1000mg Soft Capsules
Product Code: C10AX06
Pharmaceutical Form: Capsule, soft
Sponsors
Rode Kruis Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Females undergoing laparoscopic gastric bypass surgery because of morbid obesity •Age between 18 and 60 years •Written informed consent •Able to fit in the MRI, weight circumference =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Pregnancy •Diabetes mellitus type 1 •Current history of inflammatory, infectious or malignant disease •The use of anti-inflammatory drugs •Contra-indications for the use of omega-3 fatty acids •Underwent previous bariatric procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our primary objective is to compare pre-treatment with the standard low calorie diet with pre-treatment with supplemental omega-3 fatty acids on liver volume. ;Secondary Objective: Secondary objectives are patient satisfaction about different dietary pre-treatments, the effect of omega-3 fatty acids before and after bariatric surgery on immune function, including adipose tissue macrophage function, cortisol response, erythrocyte function, and the long term effect of bariatric surgery on immune function and erythrocyte function six months after surgery.;Primary end point(s): Volume of the left hepatic lobe;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The ex-vivo inflammatory cytokine response in LPS stimulated whole blood cells before and after bariatric surgery, measured as: o TNF-alpha o IL-6 o IL-10 • The low-grade inflammatory state of adipose tissue, measured by the infiltration of macrophages, expression of Netrin-1 and Unc5b, different adopokines, cytokines, signal transduction molecules and 11ß-HSD-1 in adipose tissue biopsies • Erythrocyte deformability, measured as elongation index (EI) by the LORRCA • Erythrocyte aggregation, measured as aggregation index (AI) by the LORRCA • Cortisol response, measured with ACTH-stimulation test • Serum levels of cytokines before and after bariatric surgery, measured as: o TNF-alpha o IL-6 o IL-10 • Serum levels of C-reactive protein, HDL-cholesterol, LDL-cholesterol, triglycerides and fasting glucose • Weight, height and BMI • Postoperative outcome;Timepoint(s) of evaluation of this end point: 4 weeks, first postoperative day and after 6 months | — |
Countries
Netherlands
Contacts
Public ContactRick van den Helder
Medisch Centrum Alkmaar
Outcome results
None listed