Fish oil in surgery for obesity, effects on liver volume, immune response and red blood cell functio

• Conditions: Patients qualified for bariatric surgery; MedDRA version: 17.1Level: LLTClassification code 10068900Term: Bariatric surgerySystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-004750-24-NL
• Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-06
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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 <130cm, bodyweight <220kg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): •The ex-vivo inflammatory cytokine response in LPS stimulated whole blood cells before and after bariatric surgery, measured as:<br>oTNF-alpha<br>oIL-6<br>oIL-10<br>•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<br>•Erythrocyte deformability, measured as elongation index (EI) by the LORRCA<br>•Erythrocyte aggregation, measured as aggregation index (AI) by the LORRCA<br>•Cortisol response, measured with ACTH-stimulation test<br>•Serum levels of cytokines before and after bariatric surgery, measured as:<br>oTNF-alpha<br>oIL-6<br>oIL-10<br>•Serum levels of C-reactive protein, HDL-cholesterol, LDL-cholesterol, triglycerides and fasting glucose<br>•Weight, height and BMI<br>•Postoperative outcome;Timepoint(s) of evaluation of this end point: 4 weeks, first postoperative day and after 6 months