Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function

Phase 4

Completed

• Conditions: Morbid Obesity
• Interventions: Behavioral: Low calorie diet; Drug: Omega-3 fatty acid capsules

• Registration Number: NCT02206256
• Lead Sponsor: Medical Center Alkmaar

Brief Summary

Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery are routinely pre-treated with a low calorie diet in order to reduce liver volume and to facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty acids has similar effects on liver volume, but a prospective comparison of both treatments has not been performed yet. Morbidly obese patients respond differently to surgical stress, due to a number of factors. First, obesity is associated with a low-grade inflammatory state induced by an increased amount of macrophages in adipose tissue. This state is associated with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune response to infections. Second, obesity is associated with an altered cortisol metabolism possibly related to adrenal insufficiency. This could play an important role in the altered response to surgical stress and postoperative complications in obese subjects. Third, obesity is associated with altered erythrocyte function, including decreased erythrocyte deformability and increased aggregation, factors contributing to an impaired microcirculation.

This study has a number of different aims. First, we will compare pre-treatment with the standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the stress response of obese subjects before and erythrocyte function. Third, we will investigate the effect of gastric bypass surgery by comparing values before surgery with values on the first postoperative day and 6 months after surgery regarding to immunological parameters, stress response and erythrocyte function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-01
• Study Start: 2014-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-28
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Females undergoing laparoscopic gastric bypass surgery because of morbid obesity
• Age between 18 and 65 years
• Able to fit in the MRI
• Written informed consent

Exclusion Criteria

• Pregnancy
• Diabetes mellitus type 1
• Current history of inflammatory, infectious or malignant disease
• Daily use of anti-inflammatory drugs
• Contra-indications for MRI imaging
• Contra-indications for the use of omega-3 fatty acids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low calorie diet	Low calorie diet	Low calorie diet 2 weeks pre-operatively
Omega-3 fatty acid capsules	Omega-3 fatty acid capsules	2 times a day 1 capsule for 4 weeks before gastric bypass surgery

Primary Outcome Measures

Name	Time	Method
Liver volume	baseline, after treatment	liver volume of the left hepatic lobe measured by MRI

Secondary Outcome Measures

Name	Time	Method
Peri-operative ex vivo LPS stimulated cytokine production capacity	baseline, operation day, postoperative day 1, follow up 6 months	IL-6, IL-10, TNF-alpha
Macrophage infiltration in omentum fat biopsies	Biopsies during gastric bypass surgery
Erythrocyte function	baseline, day of surgery, postoperative day 1, follow up 6 months	Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)
Cortisol response	baseline, operation day, postoperative day 1, follow up 6 months	ACTH stimulation test
Serum parameters of inflammatory response	baseline, operation day, postoperative day 1, follow up 6 months	IL-6, IL-10, TNF-alpha and C-reactive protein
Assessment of the approach of the gastro-oesophageal junction	During gastric bypass surgery	Surgeons fill out a questionnaire after the gastric bypass surgery
Patient satisfaction with intervention	After the pre-operative treatment	Questionnaire

Trial Locations

Locations (1)

Rode Kruis Ziekenhuis; 🇳🇱 Beverwijk, Noord Holland, Netherlands