Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bariatric Surgery Candidate
  • FATTY LIVER
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 21 years and 65 years
Gender
Both males and females

Description

A total of 50 subjects booked for Bariatric Surgery with BMI up 45 will be recruited. Patients with pre-existing liver disease, excessive alcohol consumption and significant central obesity will be excluded. Ultrasound examination of the liver with liver volume measurement, and blood tests, includin...

A total of 50 subjects booked for Bariatric Surgery with BMI up 45 will be recruited. Patients with pre-existing liver disease, excessive alcohol consumption and significant central obesity will be excluded. Ultrasound examination of the liver with liver volume measurement, and blood tests, including Liver Function Tests (LFT) and platelet counts,is performed as part of the pre surgery work up. The subjects are then given 4 weeks of Omega-3 supplements (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day: Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)). Just before Surgery, a repeat of ultrasound examination and measurement of liver volume is carried out, as well as a repeat liver panel and platelet count.The subjects will have their weight and body composition recorded as well at this time. At the time of the surgery, the surgeon makes a subjective assessment of the left lobe liver volume on a scale of 1 to 5, 5 being the largest. Additionally,ease of access to area under the left lobe of the liver is also subjectively assessed, on a scale of 1 to5, 5 being the most difficult.

Tracking Information

NCT #
NCT03972319
Collaborators
Not Provided
Investigators
Principal Investigator: Anton Cheng, MBBS FRCS Khoo Teck Puat Hospital Principal Investigator: Deborah Ng, MBBS MMed Khoo Teck Puat Hospital Study Director: Tan Chun Hai, MBBS FRCS Khoo Teck Puat Hospital Study Director: Lim Kheng Tian, MBBS FRCS Khoo Teck Puat Hospital Study Director: Tan Bo Chuan, MBBS FRCS Khoo Teck Puat Hospital Study Director: Babu Suresh Balasubramaniam, MBBS FRCR Khoo Teck Puat Hospital