Trial Information

The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease

35 consecutive patients referred for bariatric surgery will be recruited either at the
obesity clinic, or from inpatient (scheduled for bariatric surgery). A detailed history and
a complete physical examination will be done at the first visit along with anthropometric
measures; routine blood tests, liver function, hormonal assessment, and certain metabolic
and inflammatory markers will be evaluated. They will also have an abdominal ultrasound for
initial NAFLD assessment, fibroscan to detect liver fibrosis, and an MRI to measure hepatic
fat content and body fat composition including intra-abdominal and extra-abdominal fat.
These patients will be asked to lose a certain amount of kilos (depending on their BMI and
the surgeon preference) out of their original weight, in order to become candidates for
bariatric surgery at King Saud University Hospital (KKUH).

At the second visit, (if they lose the recommended amount weight) we will assess their
weight loss; obtain blood for the same hormonal and inflammatory markers assessment.
Nonetheless, if they did not lose weight and the treating surgeon gave them a third
appointment, we will consider their third visit as a second visit; preforming all the
investigations mentioned above. In this case we will interpret their results with respect to
the total duration of "before surgery" weight loss.

During the operation, tissue biopsy will be taken with a core needle biopsy for the liver
and a sharp non-thermal instrument for subcutaneous fat, visceral fat, and abdominal muscle
immediately after skin incision. A CAP certified tissue manager would process all tissues.
Liver biopsy will be sliced it to two parts; the first half is for histological evaluation,
but the other half will be stored for tissue studies. The histologic slides will be stained
with hematoxylin and eosin (H&E), and Masson Trichrome stains for microscopic evaluation.
This evaluation will be provided by a single histopathologist who will be blinded to the
patients' clinical condition, and the order of the biopsy.

Follow Up:

After the surgery follow up appointments will be scheduled 3 months, 6 months, 1 year, and
annually till 5 years. The followings will be done in each visit:

1. Thorough physical exam as per the CRF.

2. Take a blood sample to evaluate liver function, metabolic, and inflammatory changes
using the same parameters as those in the baseline.

3. Request for: fibroscan and abdominal ultrasound. Second, third and fourth liver
biopsies will be taken percutaneously 3 months, 1 year, and 5 years following the
initial biopsy respectively. These biopsies will be obtained using core tissue biopsy
with ultrasound guidance for the same histological assessment and tissue studies.
Another MRI will be schedule 1 year after the surgery.

Specimens collected under this trial will be part of the King Saud University Liver Disease
Research Centre Biobanking and will follow all policy and procedures within the biobanking
protocol as approved by the IRB committee.