Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function (OLIVIER)
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Omega-3 fatty acid capsules
Low calorie diet
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
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
Sites / Locations
- Rode Kruis Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low calorie diet
Omega-3 fatty acid capsules
Arm Description
Low calorie diet 2 weeks pre-operatively
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Outcomes
Primary Outcome Measures
Liver volume
liver volume of the left hepatic lobe measured by MRI
Secondary Outcome Measures
Peri-operative ex vivo LPS stimulated cytokine production capacity
IL-6, IL-10, TNF-alpha
Macrophage infiltration in omentum fat biopsies
Erythrocyte function
Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)
Cortisol response
ACTH stimulation test
Serum parameters of inflammatory response
IL-6, IL-10, TNF-alpha and C-reactive protein
Assessment of the approach of the gastro-oesophageal junction
Surgeons fill out a questionnaire after the gastric bypass surgery
Patient satisfaction with intervention
Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02206256
Brief Title
Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Acronym
OLIVIER
Official Title
Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Center Alkmaar
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low calorie diet
Arm Type
Active Comparator
Arm Description
Low calorie diet 2 weeks pre-operatively
Arm Title
Omega-3 fatty acid capsules
Arm Type
Active Comparator
Arm Description
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Intervention Type
Drug
Intervention Name(s)
Omega-3 fatty acid capsules
Other Intervention Name(s)
purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)
Intervention Description
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Intervention Type
Behavioral
Intervention Name(s)
Low calorie diet
Intervention Description
A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
Primary Outcome Measure Information:
Title
Liver volume
Description
liver volume of the left hepatic lobe measured by MRI
Time Frame
baseline, after treatment
Secondary Outcome Measure Information:
Title
Peri-operative ex vivo LPS stimulated cytokine production capacity
Description
IL-6, IL-10, TNF-alpha
Time Frame
baseline, operation day, postoperative day 1, follow up 6 months
Title
Macrophage infiltration in omentum fat biopsies
Time Frame
Biopsies during gastric bypass surgery
Title
Erythrocyte function
Description
Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)
Time Frame
baseline, day of surgery, postoperative day 1, follow up 6 months
Title
Cortisol response
Description
ACTH stimulation test
Time Frame
baseline, operation day, postoperative day 1, follow up 6 months
Title
Serum parameters of inflammatory response
Description
IL-6, IL-10, TNF-alpha and C-reactive protein
Time Frame
baseline, operation day, postoperative day 1, follow up 6 months
Title
Assessment of the approach of the gastro-oesophageal junction
Description
Surgeons fill out a questionnaire after the gastric bypass surgery
Time Frame
During gastric bypass surgery
Title
Patient satisfaction with intervention
Description
Questionnaire
Time Frame
After the pre-operative treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.P.J. Houdijk, Dr.
Organizational Affiliation
Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rode Kruis Ziekenhuis
City
Beverwijk
State/Province
Noord Holland
ZIP/Postal Code
1942 LE
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
30888593
Citation
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.
Results Reference
derived
Learn more about this trial
Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
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