ER Stress in NAFLD

Withdrawn before enrolling · Early Phase 1

Conditions studied: Obesity, NAFLD

In brief

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 phenotype in obese humans. The investigators plan to examine this hypothesis in a well-characterized cohort of obese subjects that are scheduled for bariatric surgery. Methyl-D9-choline chloride will be infused before and after a 2-week high fructose or glucose feeding to determine the biosynthesis and kinetics of secretory lipoprotein phospholipids. It is proposed that phospholipid metabolism play an important role in the pathogenesis or etiology of fatty liver in non-alcoholic conditions through mechanisms that invoke ER and oxidative stress responses.

Key facts

Study ID

NCT01807910

Run by

Vanderbilt University

People needed

0

Starts

2013-10-01

Expected to finish

2018-04-01

Last updated by the study team

2013-10-23

Who can join

Age: 30 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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