Trial | NCT02206256  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    62
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.
Study Started
Nov 30
2014
Primary Completion
Nov 30
2016
Study Completion
Nov 30
2016
Last Update
Jul 31
2018

Drug Omega-3 fatty acid capsules

2 times a day 1 capsule for 4 weeks before gastric bypass surgery

  • Other names: purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)

Behavioral Low calorie diet

A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.

Low calorie diet Active Comparator

Low calorie diet 2 weeks pre-operatively

Omega-3 fatty acid capsules Active Comparator

2 times a day 1 capsule for 4 weeks before gastric bypass surgery

Criteria 

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
No Results Posted