Preoperative Omega-3 Polyunsaturated Fatty Acids in Morbidly Obese to Reduce Liver Volume and Steatosis
Condition: Morbid Obesity D009765
MeSH terms: Obesity, Morbid
Study type: Interventional

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.
    


Intervention name(s): Omega-3 Fatty Acid; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention