Clinical trial NCT02206256: Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Official title: Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Liver volume
timeFrame: baseline, after treatment
Secondary outcomes:
measure: Peri-operative ex vivo LPS stimulated cytokine production capacity
timeFrame: baseline, operation day, postoperative day 1, follow up 6 months
measure: Macrophage infiltration in omentum fat biopsies
timeFrame: Biopsies during gastric bypass surgery
measure: Erythrocyte function
timeFrame: baseline, day of surgery, postoperative day 1, follow up 6 months
measure: Cortisol response
timeFrame: baseline, operation day, postoperative day 1, follow up 6 months
measure: Serum parameters of inflammatory response
timeFrame: baseline, operation day, postoperative day 1, follow up 6 months
measure: Assessment of the approach of the gastro-oesophageal junction
timeFrame: During gastric bypass surgery
measure: Patient satisfaction with intervention
timeFrame: After the pre-operative treatment
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
state: Noord Holland
Study officials:
affiliation: Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar
name: A.P.J. Houdijk, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakker N, van den Helder RS, Geenen RWF, Hunfeld MA, Cense HA, Demirkiran A, Houdijk APJ. Four Weeks of Preoperative Omega-3 Fatty Acids Reduce Liver Volume: a Randomised Controlled Trial. Obes Surg. 2019 Jul;29(7):2037-2044. doi: 10.1007/s11695-019-03814-7.