Phospholipid Endoplasmic Reticulum Stress in Nonalcoholic Fatty Liver Disease
methyl-D9-choline
+ methyl-D9-choline
Body Weight+9
+ Digestive System Diseases
+ Liver Diseases
Basic Science Study
Summary
Study start date: October 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 30 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 Criteria: 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Vanderbilt University Medical Center
Nashville, United StatesOpen Vanderbilt University Medical Center in Google Maps