Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.
| Status: | Archived |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
It is known that a vast majority of patients seeking a bariatric surgery weight reduction
procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients
within this group have a more serious liver problem known as nonalcoholic steatohepatitis
(NASH). NASH is a serious liver disease that can lead to cirrhosis, liver failure and
ultimately liver transplantation. The purpose of this study is to explore the effects of
bariatric surgery on the progression of NASH. The investigators also hope to gain insight
into which genes may be responsible for the development of NAFLD and NASH. The knowledge
gained from this study will advance the field of fatty liver disease and help design
rational treatments to prevent disease progression.
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver tests in
the United States. NAFLD is often found in association with obesity and diabetes and it is
expected to become increasingly prevalent as the incidence of diabetes and obesity continues
to increase. NAFLD represents a range of diseases from simple fatty deposition in the liver
to more aggressive inflammation and fibrosis, termed nonalcoholic steatohepatitis (NASH).
The distinction of NASH as an entity within NAFLD is an important one, as the natural
history of this disease is different. Ultimately, NASH may progress to cirrhosis in up to
25% of patients, compared to simple steatosis which is a benign condition.
NAFLD has been estimated at 10-24% in various populations and is significantly higher in
obese populations (57.5-74%). NASH is a subset of NAFLD characterized by fatty change with
lobular inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. The
bariatric surgery population is an ideal cohort to study a large subset of NASH; those with
morbid obesity.
The purpose of this study is to examine variability of hepatic histology as well as
expression of key metabolic genes in NAFLD/NASH patients undergoing bariatric surgery.
Patients will undergo pre-operative laboratory testing, followed by intra-operative liver
and fat biopsies. A 12-month follow up will consist of repeat liver biopsy and laboratory
testing. We predict that histologic variability of inflammation and fibrosis in NASH is
accompanied by differential gene expression. Furthermore, if this variability is
pronounced, this will temper the reliance on percutaneous liver biopsy in NASH as the “gold
standard†and further emphasize the need for global markers of disease progression.
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