MedDataX Logo

ER Stress in NAFLD

NCT ID: NCT01807910

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity NAFLD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Obesity NAFLD NASH Steatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fructose

Participants will receive fructose (3g/kg/day) for 2 weeks.

Group Type EXPERIMENTAL

methyl-D9-choline

Intervention Type DRUG

Subjects in both arms will be infused with methyl-D9-choline in order to assess the biosynthesis and kinetics of secretory lipoprotein phospholipids.

Glucose

Participants will receive glucose (3g/kg/day) for 2 weeks.

Group Type ACTIVE_COMPARATOR

methyl-D9-choline

Intervention Type DRUG

Subjects in both arms will be infused with methyl-D9-choline in order to assess the biosynthesis and kinetics of secretory lipoprotein phospholipids.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

methyl-D9-choline

Subjects in both arms will be infused with methyl-D9-choline in order to assess the biosynthesis and kinetics of secretory lipoprotein phospholipids.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charles R. Flynn

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charles R Flynn, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Naji N Abumrad, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ER stress

Identifier Type: -

Identifier Source: org_study_id