Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00887393
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00887393
Study Brief:
Protocol Section:
NCT00887393