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

Morbid Obesity Clinical Trial

— OLIVIER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206256
• Other study ID #: NL47021.029.13
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: July 2018
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• Omega-3 fatty acid capsules
2 times a day 1 capsule for 4 weeks before gastric bypass surgery

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

Locations

Country	Name	City	State
Netherlands	Rode Kruis Ziekenhuis	Beverwijk	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome

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