Status:
COMPLETED
Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.
Lead Sponsor:
Northwestern University
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Brief Summary
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...
Detailed Description
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 beco...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00280527
Start Date
September 1 2006
End Date
September 1 2008
Last Update
December 20 2011
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611