Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatments omega-3 fatty acid capsules, low calorie diet
Phase phase 4
Sponsor Medical Center Alkmaar
Start date November 2014
End date September 2016
Trial size 62 participants
Trial identifier NCT02206256, NL47021.029.13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Low calorie diet 2 weeks pre-operatively
low calorie diet
A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
(Active Comparator)
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
omega-3 fatty acid capsules purified fish oil
2 times a day 1 capsule for 4 weeks before gastric bypass surgery

Primary Outcomes

Measure
Liver volume
time frame: baseline, after treatment

Secondary Outcomes

Measure
Peri-operative ex vivo LPS stimulated cytokine production capacity
time frame: baseline, operation day, postoperative day 1, follow up 6 months
Macrophage infiltration in omentum fat biopsies
time frame: Biopsies during gastric bypass surgery
Erythrocyte function
time frame: baseline, day of surgery, postoperative day 1, follow up 6 months
Cortisol response
time frame: baseline, operation day, postoperative day 1, follow up 6 months
Serum parameters of inflammatory response
time frame: baseline, operation day, postoperative day 1, follow up 6 months
Assessment of the approach of the gastro-oesophageal junction
time frame: During gastric bypass surgery
Patient satisfaction with intervention
time frame: After the pre-operative treatment

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Principal investigator A.P.J. Houdijk, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medical Center Alkmaar.