Status:
WITHDRAWN
ER Stress in NAFLD
Lead Sponsor:
Vanderbilt University
Conditions:
Obesity
NAFLD
Eligibility:
FEMALE
30-60 years
Phase:
EARLY_PHASE1
Brief Summary
The investigators overall hypothesis is that exacerbation of endoplasmic reticulum (ER) stress in the liver is associated with significant alterations in phosphatidylcholines that drive the NASH pheno...
Eligibility Criteria
Inclusion
- Ambulatory females age 30-60 years old
- Women of all ethnic groups
- BMI≥35 kg/m2
- Approval for Roux-en-Y gastric bypass or sleeve gastrectomy.
Exclusion
- Smoking \>7 cigarettes per day
- Previous malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Recent history of neoplasia (\<5 years ago)
- Malabsorptive syndromes
- Inflammatory intestinal disease
- Patients with established organ dysfunction
- Diagnosis of type 1 or type 2 diabetes mellitus or current use of anti-diabetic medication (last 30 days; last 60days for thiazolidinediones)
- Diagnosed hyperbetalipoproteinemia or hypobetalipoproteinemia
- Patients on cholesterol lowering medicines
- Vegan diet
- Hepatic fat content \<10% by MRI
- Inability to comply with study protocol such as unable to make study visits or be available daily for phone contact
- Any condition which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, chronic back pain limiting ability to lay flat, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01807910
Start Date
October 1 2013
End Date
April 1 2018
Last Update
October 23 2013
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232