Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.

Completed

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00280527

Run by

Northwestern University

People needed

43

Starts

2006-09-01

Expected to finish

2008-09-01

Last updated by the study team

2011-12-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be willing to give written informed consent
• Subjects must fulfill the criteria for bariatric surgery that have been recommended by a National Institutes of Health (NIH) consensus conference.
• These criteria include:
• The patient should be greater than 100 pounds above desirable body weight or a Body Mass Index (BMI) >40 kg/m2.
• Presence of significant obesity-related illnesses with a BMI of 35-40 kg/m2.
• Failure of sustained weight loss on supervised dietary and/or medical regimens.
• Patient shows understanding of the risks and benefits of surgery and understands lifestyle changes subsequent to the operation.
• Acceptable operative risk.
• Adult subjects 18-65 years of age of any race or gender

You may not qualify if…

• Anti - smooth muscle Ab < 1:80.
• Serum Hepatitis B surface antigen (HepBsAg) negative.
• Serum Hepatitis C Antibody (HepC Ab) negative
• Iron/TIBC ratio (transferrin saturation) < 45%
• Alpha-1-antitrypsin level within normal limits
• Ceruloplasmin level within normal limits.
• Negative pregnancy test (females)
• No active drug abuse or within 6 months
• Etoh consumption < 20g/day (males) or < 10 g/day (females) - Assessed by one physician and confirmed with one family member.
• No known diagnosis of malignancy
• Any other conditions which the investigator feels would make the subject unsuitable for enrollment, or could interfere with the subject completing the protocol.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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