Morbid ObesityPhase 4OLIVIERNCT02206256
Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
A Phase 4 study testing Omega-3 fatty acid capsules and Low calorie diet in people with Morbid Obesity, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Omega-3 fatty acid capsules and Low calorie diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Omega-3 fatty acid capsules, Low calorie diet
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid capsulesDrug
Also called purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Low calorie dietBehavioural
A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
| Study group | Role | What they receive |
|---|---|---|
| Low calorie diet | Active comparator | Low calorie diet 2 weeks pre-operatively Receives: Behavioral: Low calorie diet |
| Omega-3 fatty acid capsules | Active comparator | 2 times a day 1 capsule for 4 weeks before gastric bypass surgery Receives: Drug: Omega-3 fatty acid capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver volume
liver volume of the left hepatic lobe measured by MRI
Measured: baseline, after treatment
Secondary outcomes (7)
Peri-operative ex vivo LPS stimulated cytokine production capacity
IL-6, IL-10, TNF-alpha
Measured: baseline, operation day, postoperative day 1, follow up 6 months
Macrophage infiltration in omentum fat biopsies
Measured: Biopsies during gastric bypass surgery
Erythrocyte function
Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)
Measured: baseline, day of surgery, postoperative day 1, follow up 6 months
Cortisol response
ACTH stimulation test
Measured: baseline, operation day, postoperative day 1, follow up 6 months
Serum parameters of inflammatory response
IL-6, IL-10, TNF-alpha and C-reactive protein
Measured: baseline, operation day, postoperative day 1, follow up 6 months
Assessment of the approach of the gastro-oesophageal junction
Surgeons fill out a questionnaire after the gastric bypass surgery
Measured: During gastric bypass surgery
Patient satisfaction with intervention
Questionnaire
Measured: After the pre-operative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander P.J. Houdijk, Medical Center Alkmaar
- Investigators
- A.P.J. Houdijk, Dr., Principal investigator, Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206256
- Sponsor's protocol ID
- NL47021.029.13
- Acronym
- OLIVIER
- Status last verified
- Jul 2018
- First submitted
- 29 Jul 2014
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30888593
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
- ClinicalTrials.gov ID
- NCT02206256
- Acronym / sponsor ID
- OLIVIER / NL47021.029.13
- Conditions
- Morbid Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low calorie diet | Active comparator | Behavioral: Low calorie dietLow calorie diet 2 weeks pre-operatively |
| Omega-3 fatty acid capsules | Active comparator | Drug: Omega-3 fatty acid capsules2 times a day 1 capsule for 4 weeks before gastric bypass surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Diabetes mellitus type 1
- Current history of inflammatory, infectious or malignant disease
- Daily use of anti-inflammatory drugs
- Contra-indications for MRI imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid capsulesAlso: purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)2 times a day 1 capsule for 4 weeks before gastric bypass surgery | Drug | Omega-3 fatty acid capsules |
| Low calorie dietA low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet. | Behavioural | Low calorie diet |
Primary outcome
Liver volume
Time frame: baseline, after treatment
liver volume of the left hepatic lobe measured by MRI
7 secondary outcomes
Peri-operative ex vivo LPS stimulated cytokine production capacity
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
Macrophage infiltration in omentum fat biopsies
Time frame: Biopsies during gastric bypass surgery
Erythrocyte function
Time frame: baseline, day of surgery, postoperative day 1, follow up 6 months
Cortisol response
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
Serum parameters of inflammatory response
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
Assessment of the approach of the gastro-oesophageal junction
Time frame: During gastric bypass surgery
Patient satisfaction with intervention
Time frame: After the pre-operative treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 30888593Bakker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.P.J. Houdijk, Dr. principal investigator
Rode Kruis Ziekenhuis, Medisch Centrum Alkmaar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 fatty acid capsules and Low calorie diet in people with Morbid Obesity, run by Medical Center Alkmaar at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver volume (time frame: baseline, after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.