Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rohit Loomba, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01643512
First received: July 16, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition
Liver Disease

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Biospecimen Retention:   Samples With DNA

serum, plasma, urine, stool, DNA


Estimated Enrollment: 500
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Following an information session during which the primary consent document, a genetic sampling consent document and the UCSD HIPPA forms are reviewed, discussed and signed, the following tests and procedures will be done. For each subject, the study visit will be for 3-4 hours.

  1. Subjects will undergo a detailed history, physical examination, anthropometrics and vital signs including blood pressure and pulse. Standardized questionnaires including the Alcohol Use Disorders Identification Tests (AUDIT) and Skinner Lifetime Drinking History will be used to identify alcohol use as a cause of fatty liver disease. A trained investigator will measure waist/hip ratio at the same time as other measures are taken. The Body Mass Index (BMI) will be as calculated by measuring each subject's weight (Kg) and height (m) with empty bowel and bladder and using the formula: BMI = weight (kg)/ height (m)2.
  2. Blood tests: Participants will undergo phlebotomy, after an overnight fast, for complete metabolic panel (including liver function tests), complete blood count, protime, lipid panel, free fatty acids, serum insulin, hemoglobin A1C, fasting glucose, hepatitis B surface antigen, hepatitis C antibody, prothrombin time and HIV. 30ml of blood will be collected: including 5ml of serum banking, 5ml of plasma banking, 5ml of DNA banking, and 15ml for planned labs as listed above. Plasma will be stored for adipocytokines and testing of novel genes or biomarkers for NALFD in later studies. Fasting plasma glucose and plasma insulin levels will be obtained. Insulin resistance will be measured by HOMA-IR, the homeostasis assessment model of insulin resistance, where HOMA-IR (mmol/L x µU/ml) = fasting glucose (mmol/L) x fasting insulin (µU/ml)/22.5). The participants will be required to provide a stool and urine sample as well.
  3. A urine pregnancy test will be performed for all women of childbearing age. Women who have had hysterectomies are excluded from pregnancy testing. If the pregnancy test is positive, the patient will not be enrolled in the study.
  4. The patient will undergo magnetic resonance imaging for hepatic fat fraction.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Subjects must be at least 18 years of age
  2. The subject is willing and able to complete all procedures and observations specified in the protocol
  3. 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.

Exclusion Criteria:

  1. The subject is a female who is pregnant or nursing.
  2. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643512

Contacts
Contact: Archana Bhatt 619-471-3915 abhatt@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Archana R Bhatt    619-471-3915    abhatt@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Rohit Loomba UCSD
  More Information

Additional Information:
No publications provided

Responsible Party: Rohit Loomba, Assistant Professor of Clinical Medicine, Division of Gastroenterology, Department of Medicine and, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01643512     History of Changes
Other Study ID Numbers: 111282
Study First Received: July 16, 2012
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014