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NCT Number: NCT02206256

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rode Kruis Ziekenhuis

Beverwijk, North Holland, 1942 LE, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid capsules

Drug

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

Other names: purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)

Low calorie diet

Behavioral

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

Primary outcomes

  1. Liver volume

    Time frame: baseline, after treatment

    liver volume of the left hepatic lobe measured by MRI

Secondary outcomes

  1. Peri-operative ex vivo LPS stimulated cytokine production capacity

    Time frame: baseline, operation day, postoperative day 1, follow up 6 months

    IL-6, IL-10, TNF-alpha

  2. Macrophage infiltration in omentum fat biopsies

    Time frame: Biopsies during gastric bypass surgery

  3. Erythrocyte function

    Time frame: baseline, day of surgery, postoperative day 1, follow up 6 months

    Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)

  4. Cortisol response

    Time frame: baseline, operation day, postoperative day 1, follow up 6 months

    ACTH stimulation test

  5. Serum parameters of inflammatory response

    Time frame: baseline, operation day, postoperative day 1, follow up 6 months

    IL-6, IL-10, TNF-alpha and C-reactive protein

  6. Assessment of the approach of the gastro-oesophageal junction

    Time frame: During gastric bypass surgery

    Surgeons fill out a questionnaire after the gastric bypass surgery

  7. Patient satisfaction with intervention

    Time frame: After the pre-operative treatment

    Questionnaire

Sponsors and collaborators

Lead sponsor

Medical Center Alkmaar

Other

Registry information

Acronym: OLIVIER

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2014
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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