Preoperative Omega-3 Polyunsaturated Fatty Acids in Morbidly Obese to Reduce Liver Volume and Steatosis

NCT03006016 | Completed

• 1 other identifier: 15-API-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Morbid Obesity D009765

Outcome Measures

Primary Outcomes (1)

• 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)

  4 weeks

Secondary Outcomes (2)

• The whole liver volume

  4 weeks

• The liver injuries

  4 weeks

Other Outcomes (1)

• the liver steatosis

  4 weeks

Study Arms (2)

Omega 3

EXPERIMENTAL

The patient will take Omega 3 before intervention 4-week course of 1.500 Mg/ day without caloric restriction

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

Other: Placebo

Interventions

Omega-3 Fatty Acid DRUG

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.

Omega 3

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice - Chirurgie Digestive- Hôpital Archet

Nice, Alpes-maritimes, 06200, France

Location

CHU de Montpellier - Chirurgie digestive

Montpellier, Languedoc - Roussillon, 34000, France

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• IANNELLI Antonio, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 30, 2016
• Study Start: April 12, 2017
• Primary Completion: March 31, 2020
• Study Completion: August 7, 2020
• Last Updated: February 21, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)