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

NCT ID: NCT02206256

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low calorie diet

Low calorie diet 2 weeks pre-operatively

Group Type: ACTIVE_COMPARATOR

Low calorie diet

Intervention Type: BEHAVIORAL

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

Omega-3 fatty acid capsules

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

Group Type: ACTIVE_COMPARATOR

Omega-3 fatty acid capsules

Intervention Type: DRUG

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

Interventions

Omega-3 fatty acid capsules

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

Intervention Type: DRUG

Low calorie diet

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

Intervention Type: BEHAVIORAL

Other Intervention Names

purified fish oil; omega-3 fatty acids; eicosapentoenoic acid (EPA); docosahexaenoic acid (DHA)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Responsible Party

Alexander P.J. Houdijk

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A.P.J. Houdijk, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar

Locations

Rode Kruis Ziekenhuis

Beverwijk, North Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 30888593 (View on PubMed)

Other Identifiers

NL47021.029.13

Identifier Type: -

Identifier Source: org_study_id