NCT03683589

Brief Summary

NAFLD is the most prevalent liver disease in the U.S., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (NASH). Previous studies has shown that elevated de novo lipogenesis (DNL) is the unique, early event distinguishing patients with NAFLD from equally-obese subjects with low IHTG. The purpose of this study is to directly by measure DNL in human liver tissue and comparing it to liver histological scores from patient biopsies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

December 19, 2024

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

September 20, 2018

Last Update Submit

December 16, 2024

Conditions

Nonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisBariatric Surgery CandidateObesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • De novo lipogenesis

    DNL will be measured directly in the liver biopsies

    Dec 2019

Secondary Outcomes (3)

  • Histological scores (NAFLD activity score)

    Dec 2019

  • Liver enzymes

    Dec 2019

  • FibroScan

    Dec 2019

Study Arms (1)

Study group

Participants will receive deuterated water for 10 days before undergoing bariatric surgery. Liver biopsy collected, lipids extracted and DNL measured via GC/MS.

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes both obese men and women who are undergoing bariatric surgery

You may not qualify if:

  • Men and women (pre and post-menopausal)
  • Overweight/obese with BMI ≥ 25.9 or ≤ 50.0 kg/m2
  • Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type II
  • years of age
  • use of tobacco products or no use of these products
  • Sedentary, ≤ 60 minutes per week of structured physical activity
  • The following conditions exclude subjects for this project because bariatric surgery would not be performed in these populations. Individuals with acute disease or advanced cardiac, liver, or renal disease, excessive alcohol use, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 year. Women pregnant or trying to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (3)

  • Lambert JE, Ramos-Roman MA, Browning JD, Parks EJ. Increased de novo lipogenesis is a distinct characteristic of individuals with nonalcoholic fatty liver disease. Gastroenterology. 2014 Mar;146(3):726-35. doi: 10.1053/j.gastro.2013.11.049. Epub 2013 Dec 4.

    PMID: 24316260BACKGROUND

  • Donnelly KL, Smith CI, Schwarzenberg SJ, Jessurun J, Boldt MD, Parks EJ. Sources of fatty acids stored in liver and secreted via lipoproteins in patients with nonalcoholic fatty liver disease. J Clin Invest. 2005 May;115(5):1343-51. doi: 10.1172/JCI23621.

    PMID: 15864352BACKGROUND

  • Syed-Abdul MM, Moore MP, Wheeler AA, Ganga RR, Diaz-Arias A, Petroski GF, Rector RS, Ibdah JA, Parks EJ. Isotope Labeling and Biochemical Assessment of Liver-Triacylglycerol in Patients with Different Levels of Histologically-Graded Liver Disease. J Nutr. 2023 Dec;153(12):3418-3429. doi: 10.1016/j.tjnut.2023.09.018. Epub 2023 Sep 27.

    PMID: 37774841DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be stored in a -80C freezer. Liver samples will be tested immediately and will not be stored.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesity, Morbid

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth J Parks, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 25, 2018

Study Start

February 1, 2019

Primary Completion

August 21, 2019

Study Completion

July 31, 2020

Last Updated

December 19, 2024

Record last verified: 2020-10

Locations

US(1)