Status:
COMPLETED
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Morbid Obesity
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver. The impact of NAFLD on bariatric surgery is of great concern. Enlarged fatty livers increase the operative c...
Detailed Description
The obesity epidemic has lead to increased morbidity and morality from cardiovascular disease and Type 2 diabetes. One co-morbidity of obesity is nonalcoholic fatty liver disease (NAFLD), which is cha...
Eligibility Criteria
Inclusion
- Participants will be deemed as appropriate candidates by the University of Michigan Bariatric Surgery multidisciplinary committee to undergo laparoscopic Roux-Y gastric bypass surgery or adjustable laparoscopic banding surgery
- Age 18 to 65 years
- Willing and able to give informed consent
- Clinical diagnosis of non-alcoholic fatty liver disease based on presence of abnormal LFTS and/or abnormal liver ultrasound
- Able to have an MRI procedure (able to fit into scanner, largest width \< 60 cm, weight \< 400 lbs, largest girth \< 74 inches, do not have a pacemaker, artificial limbs or any other medical devices that contain iron that may be affected by the MRI procedure).
- Willing and able to tolerate the MRI procedure (use of benzodiazepines to complete the procedure is allowed if needed and deemed safe by the study team)
Exclusion
- Clinical history of diabetes or fasting glucose \> 126 mg/dl
- Alcohol consumption of \> 40 grams/week
- Any other liver disease
- BMI \< 40 kg/m2
- Unable to ambulate
- Any other factor that in the opinion of the PI or co-investigators which may impede successful completion of the study
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00887393
Start Date
April 1 2009
End Date
December 1 2012
Last Update
June 18 2013
Active Locations (1)
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1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109