An interventional study of Omega-3 Fatty Acid and Placebo in Morbid Obesity D009765, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-02-21.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
The patient will take Omega 3 before intervention 4-week course of 1.500 Mg/ day without caloric restriction
Drug: Omega-3 Fatty Acid
The patient will take placebo before intervention 4-week course of 1.500 Mg/ day without caloric restriction
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.
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 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)
Time frame: 4 weeks
The whole liver volume
Reduction of the whole liver volume (as measured on MRI)
Time frame: 4 weeks
The liver injuries
liver injuries during surgery (surgeon report)
Time frame: 4 weeks
the liver steatosis
Reduction of the whole liver steatosis (as measured on MRI)
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice