Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members
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|ClinicalTrials.gov Identifier: NCT01643512|
Recruitment Status : Unknown
Verified July 2012 by Rohit Loomba, University of California, San Diego.
Recruitment status was: Recruiting
First Posted : July 18, 2012
Last Update Posted : July 18, 2012
|Condition or disease|
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.
- 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.
- 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.
- 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.
- The patient will undergo magnetic resonance imaging for hepatic fat fraction.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643512
|Contact: Archana Bhattemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Archana R Bhatt 619-471-3915 firstname.lastname@example.org|
|Principal Investigator:||Rohit Loomba||UCSD|