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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01807910
Other study ID # ER stress
Secondary ID
Status Withdrawn
Phase Phase 0
First received March 5, 2013
Last updated October 22, 2013
Start date October 2013
Est. completion date April 2018

Study information

Verified date October 2013
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in zonation of phospholipids and PEMT in liver tissues Changes in zonation of phospholipids and PEMT in liver tissues acquired from the same subjects intraoperatively during bariatric surgery will be assessed using MALDI-IMS. 60 months No
Primary Net hepatic phospholipid production Net hepatic phospholipid production will be determined using [11C]choline dynamic Positron Emission Tomography (PET) before and after high fructose feeding for two weeks. A similar group of control obese subjects will undergo the same procedures before and after two weeks isocaloric glucose feeding. Baseline and 2 weeks No
Secondary Kinetics of secretory lipoprotein phospholipids The biosynthesis and kinetics of secretory lipoprotein phospholipids will be determined using methyl-D9-choline chloride infusion before and after high fructose (or glucose) feeding. Baseline and 2 weeks No
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