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

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ClinicalTrials.gov Identifier: NCT02206256
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander P.J. Houdijk, Medical Center Alkmaar

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: Omega-3 fatty acid capsules Behavioral: Low calorie diet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low calorie diet
Low calorie diet 2 weeks pre-operatively
Behavioral: Low calorie diet
A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.

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




Primary Outcome Measures :
  1. Liver volume [ Time Frame: baseline, after treatment ]
    liver volume of the left hepatic lobe measured by MRI


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206256


Locations
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Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Noord Holland, Netherlands, 1942 LE
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
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Principal Investigator: A.P.J. Houdijk, Dr. Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexander P.J. Houdijk, Dr., Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT02206256     History of Changes
Other Study ID Numbers: NL47021.029.13
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms