NCT01643512

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the United States. The cause of NAFLD is poorly defined but is thought to involve complex interactions of genetic and environmental factors. NAFLD is often associated with the traits of the metabolic syndrome including diabetes, high cholesterol or elevated blood pressure. Currently, there are no accurate noninvasive means of evaluating NAFLD and its more serious form which includes inflammation that may lead to severe scarring in the liver. The goal of this study is to evaluate shared genetic factors that underlie NAFLD and features of the metabolic syndrome as determined by blood work and radiographic studies in a cohort of twins and first degree relatives.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

10 years

First QC Date

July 16, 2012

Last Update Submit

May 3, 2021

Conditions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twins and first degree relatives (sibling-sibling or offspring-parent).

You may qualify if:

  • Subjects must be at least 18 years of age
  • The subject is willing and able to complete all procedures and observations specified in the protocol
  • The subject has been fully informed and has personally signed and dated the written Informed Consent/Assent and Health Insurance Portability and Accountability Act (HIPAA) provisions.

You may not qualify if:

  • The subject is a female who is pregnant or nursing.
  • Contraindications to MRI:
  • The subject has any contraindication to MR imaging, such as patients with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field.
  • The subject has a history of extreme claustrophobia.
  • The subject cannot fit inside the MR scanner cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, urine, stool, DNA

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Rohit Loomba

    UCSD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Archana Bhatt

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations