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

NCT02206256 | Completed Phase 4 DMC

• 1 other identifier: NL47021.029.13
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Liver volume

  liver volume of the left hepatic lobe measured by MRI

  baseline, after treatment

Secondary Outcomes (7)

• Peri-operative ex vivo LPS stimulated cytokine production capacity

  baseline, operation day, postoperative day 1, follow up 6 months

• Macrophage infiltration in omentum fat biopsies

  Biopsies during gastric bypass surgery

• Erythrocyte function

  baseline, day of surgery, postoperative day 1, follow up 6 months

• Cortisol response

  baseline, operation day, postoperative day 1, follow up 6 months

• Serum parameters of inflammatory response

  baseline, operation day, postoperative day 1, follow up 6 months

Study Arms (2)

Low calorie diet

ACTIVE COMPARATOR

Low calorie diet 2 weeks pre-operatively

Behavioral: Low calorie diet

Omega-3 fatty acid capsules

ACTIVE COMPARATOR

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

Drug: Omega-3 fatty acid capsules

Interventions

Omega-3 fatty acid capsules DRUG

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

Also known as: purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)

Omega-3 fatty acid capsules

Low calorie diet BEHAVIORAL

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

Low calorie diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Center Alkmaar: lead

Study Sites (1)

Rode Kruis Ziekenhuis

Beverwijk, North Holland, 1942 LE, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30888593 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids; Caloric Restriction

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• A.P.J. Houdijk, Dr.

  Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 1, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

NL (1)