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

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

Interventions

DRUG

Omega-3 Fatty Acid

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.

OTHER

Placebo

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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice

  lead OTHER

Principal Investigators

• IANNELLI Antonio, PhD · Centre Hospitalier Universitaire de Nice

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-12

Primary Completion

2020-03-31

Completion

2020-08-07

Countries

• France

Study Locations