Morbid Obesity D009765OmegobeseNCT03006016
Preoperative Omega-3 Polyunsaturated Fatty Acids in Morbidly Obese to Reduce Liver Volume and Steatosis
A study testing Omega-3 Fatty Acid in people with Morbid Obesity D009765, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the hiatal region during bariatric surgery. The doctors made a preliminary prospective study that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction resulted in a 20 % reduction in the volume of the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity D009765
- What is being tested?
- Omega-3 Fatty Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Apr 2017to 7 Aug 2020
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 60 years
- Karnofsky Index de > 70
- BMI > 35 kg/m2 associated with metabolic syndrome define by three or more of the following: waistline that measures at least 80 centimeters for european women and 94 centimeters for european men; High triglyceride level less than 1.5 g/l or specific medications; Reduced high-density lipoprotein (HDL) cholesterol less than 1.04 mmol/L in men or less than 1.3 mmol/L in women; Increased blood pressure 130/85 millimeters of mercury (mm Hg) or higher or specific medications; Elevated fasting blood sugar 100 mg/dL (5.6 mmol/L) or higher or specific médications.
- Failure of previous medical treatment of morbid obesity well conducted by a multidisciplinary team for at least 6 months.
- Multidisciplinary team agreement for bariatric surgery
- Patients affiliated to the French Health Care System (Sécurité Sociale)
- Patients having signed the informed consent
Who cannot join
- Contraindications to MRI (pace-maker, metallic foreign bodies, claustrophobia)
- Psychiatric contraindications to bariatric surgery
- Anesthesiology contraindications to surgery
- Progressive malignancies
- Chronic alcoholism (>30 gr/day)
- Uncontrolled sepsis
Show all 15Show fewer
- History of liver disease
- Renal failure (Cockroft <30ml/min)
- Long term treatment with steroids
- Regular assumption of alimentary complements enriched with proteins and/or amino acids)
- Pregnancy (pregnancy test will be done before surgery in fertile women)
- History of bariatric surgery of supramesocolic surgery rendering the access to the hiatal region difficult.
- Forseeable difficulies in completing follow-up
- Patients under judicial protection
- Patients unable to understand or put in practice medical prescription as omega-3 oral supplementation.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier - Chirurgie digestive
Montpellier, Languedoc - Roussillon, 34000
CHU de Nice - Chirurgie Digestive- Hôpital Archet
Nice, Alpes-maritimes, 06200
About this study
Official title: Impact of Preoperative 4-week Supplementation With Omega-3 Polyunsaturated Fatty Acids on Liver Volume and Steatosis to Facilitate Bariatric Surgery in Morbdly Obese Patients : the " Omegaobese Study ".
Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the hiatal region during bariatric surgery. The doctors made a preliminary prospective study that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on ultrasounds.
The aim of this study is to determine whether a 4-week preoperative course with omega-3 without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume and its fat content, rendering thus surgery easier.
Read more
The primary end point is the reduction of the volume of the left liver lobe as measured by magnetic resonance imaging.
Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver injuries during surgery, and duration of surgery, the evolution of liver tests as well as the correlation between preoperative MRI data and intraoperative liver biopsy for the quantification of liver steatosis.
Study design: This is an interventional, prospective, multicentric, randomized, double blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients in 12 months.
Study time schedule: At the time of the enrollment visit two visits are scheduled, the first before the beginning of the study and the last at the end. Surgery is scheduled no more than 7 days after the end of the treatment. At time of these two visits a clinical examination is performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein) and a MRI to evaluate the volume and the fat content of the liver. At time of surgery duration of surgery and any eventual liver injury are recorded and a liver biopsy is performed.
The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a reduction in the volume of the left liver lobe of 20 %.
Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in a significant reduction of liver volume and steatosis before bariatric surgery, it may be recommended as a systematic preoperative treatment.
- Conditions
- Morbid Obesity D009765
- Being tested
- Omega-3 Fatty Acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidDrug
The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.
PlaceboOther
The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 | Experimental | The patient will take Omega 3 before intervention 4-week course of 1.500 Mg/ day without caloric restriction Receives: Drug: Omega-3 Fatty Acid |
| Placebo | Placebo comparator | The patient will take placebo before intervention 4-week course of 1.500 Mg/ day without caloric restriction Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of the left liver lobe
Reduction of the volume of the left liver lobe as measured by magnetic resonance imaging between the beginning of the study and its end (4 weeks)
Measured: 4 weeks
Secondary outcomes (2)
The whole liver volume
Reduction of the whole liver volume (as measured on MRI)
Measured: 4 weeks
The liver injuries
liver injuries during surgery (surgeon report)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start12 Apr 2017
- Primary completion31 Mar 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid Obesity D009765Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IANNELLI Antonio, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006016
- Sponsor's protocol ID
- 15-API-03
- Acronym
- Omegobese
- Status last verified
- Sep 2021
- First submitted
- 8 Dec 2016
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative 4-week Supplementation With Omega-3 Polyunsaturated Fatty Acids on Liver Volume and Steatosis to Facilitate Bariatric Surgery in Morbdly Obese Patients : the " Omegaobese Study ".
- ClinicalTrials.gov ID
- NCT03006016
- Acronym / sponsor ID
- Omegobese / 15-API-03
- Conditions
- Morbid Obesity D009765
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 30 Dec 2016 (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.
Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the hiatal region during bariatric surgery. The doctors made a preliminary prospective study that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on ultrasounds.
The aim of this study is to determine whether a 4-week preoperative course with omega-3 without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume and its fat content, rendering thus surgery easier.
The primary end point is the reduction of the volume of the left liver lobe as measured by magnetic resonance imaging.
Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver injuries during surgery, and duration of surgery, the evolution of liver tests as well as the correlation between preoperative MRI data and intraoperative liver biopsy for the quantification of liver steatosis.
Study design: This is an interventional, prospective, multicentric, randomized, double blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients in 12 months.
Study time schedule: At the time of the enrollment visit two visits are scheduled, the first before the beginning of the study and the last at the end. Surgery is scheduled no more than 7 days after the end of the treatment. At time of these two visits a clinical examination is performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein) and a MRI to evaluate the volume and the fat content of the liver. At time of surgery duration of surgery and any eventual liver injury are recorded and a liver biopsy is performed.
The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a reduction in the volume of the left liver lobe of 20 %.
Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in a significant reduction of liver volume and steatosis before bariatric surgery, it may be recommended as a systematic preoperative treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 | Experimental | Drug: Omega-3 Fatty AcidThe patient will take Omega 3 before intervention 4-week course of 1.500 Mg/ day without caloric restriction |
| Placebo | Placebo comparator | Other: PlaceboThe patient will take placebo before intervention 4-week course of 1.500 Mg/ day without caloric restriction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 - 60 years
- Karnofsky Index de > 70
- BMI > 35 kg/m2 associated with metabolic syndrome define by three or more of the following: waistline that measures at least 80 centimeters for european women and 94 centimeters for european men; High triglyceride level less than 1.5 g/l or specific medications; Reduced high-density lipoprotein (HDL) cholesterol less than 1.04 mmol/L in men or less than 1.3 mmol/L in women; Increased blood pressure 130/85 millimeters of mercury (mm Hg) or higher or specific medications; Elevated fasting blood sugar 100 mg/dL (5.6 mmol/L) or higher or specific médications.
- Failure of previous medical treatment of morbid obesity well conducted by a multidisciplinary team for at least 6 months.
- Multidisciplinary team agreement for bariatric surgery
Key exclusion criteria (15 listed)
- Contraindications to MRI (pace-maker, metallic foreign bodies, claustrophobia)
- Psychiatric contraindications to bariatric surgery
- Anesthesiology contraindications to surgery
- Progressive malignancies
- Chronic alcoholism (>30 gr/day)
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 AcidThe enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group. | Drug | Omega 3 |
| PlaceboThe enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group. | Other | Placebo |
Primary outcome
The volume of the left liver lobe
Time frame: 4 weeks
Reduction of the volume of the left liver lobe as measured by magnetic resonance imaging between the beginning of the study and its end (4 weeks)
2 secondary outcomes
The whole liver volume
Time frame: 4 weeks
The liver injuries
Time frame: 4 weeks
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 21 Feb 2022.
- Individual participant dataSharing planned: No
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.
IANNELLI Antonio, PhD principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acid in people with Morbid Obesity D009765, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 7 inclusion and 15 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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The volume of the left liver lobe (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.