Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.
|First Received Date ICMJE||January 19, 2006|
|Last Updated Date||December 16, 2011|
|Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00280527 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.|
|Official Title ICMJE||Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.|
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
This will be a prospective trial of obese patients with presumed NAFLD undergoing bariatric surgery. Patients will be enrolled at Northwestern Memorial Hospital through the bariatric surgery clinic.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
These criteria include:
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00280527|
|Other Study ID Numbers ICMJE||1347-004|
|Has Data Monitoring Committee||No|
|Responsible Party||Mary Rinella, Northwestern University|
|Study Sponsor ICMJE||Northwestern University|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Northwestern University|
|Verification Date||December 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP