Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
381 participants
OBSERVATIONAL
2011-07-31
2017-07-31
Brief Summary
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Hypothesis 1: Common variants recently associated with variation in plasma TG levels identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD). Gene variants act in additive or synergistic manner with progressive liver fat accumulation per additional risk allele.
Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase. Furthermore, expression of lipogenic markers (SREBP1c) will increase.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric NAFLD Cohort
Overweight and obese children and adolescents at risk for non alcoholic fatty liver disease will undergo oral glucose tolerance testing (ogtt), genotyping, abdominal and liver magnetic resonance imaging (mri), and will provide a stool sample at baseline and at 2 year follow up. A small subset will undergo liver biopsy to test for hepatic steatosis and nonalcoholic steatohepatitis.
ogtt
oral glucose tolerance test
genotyping
genotyping to look for risk alleles
abdominal and liver magnetic resonance imaging
magnetic resonance imaging scan of abdomen and liver - abdominal and liver mri
stool sample
stool sample taken to investigate metabolites
liver biopsy
liver biopsy to examine for cellular change and steatosis
Interventions
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ogtt
oral glucose tolerance test
genotyping
genotyping to look for risk alleles
abdominal and liver magnetic resonance imaging
magnetic resonance imaging scan of abdomen and liver - abdominal and liver mri
stool sample
stool sample taken to investigate metabolites
liver biopsy
liver biopsy to examine for cellular change and steatosis
Eligibility Criteria
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Inclusion Criteria
* overweight or obese with a BMI greater than the 85th percentile for age and gender, and
* be otherwise healthy.
Exclusion Criteria
* no use of any antipsychotic medication
* Youth on chronic anti-inflammatory medications or who consume alcohol are also excluded.
7 Years
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Yale University
OTHER
Responsible Party
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Sonia Caprio
Principal Investigator
Principal Investigators
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Sonia Caprio, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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Burgert TS, Taksali SE, Dziura J, Goodman TR, Yeckel CW, Papademetris X, Constable RT, Weiss R, Tamborlane WV, Savoye M, Seyal AA, Caprio S. Alanine aminotransferase levels and fatty liver in childhood obesity: associations with insulin resistance, adiponectin, and visceral fat. J Clin Endocrinol Metab. 2006 Nov;91(11):4287-94. doi: 10.1210/jc.2006-1010. Epub 2006 Aug 15.
Trico D, Caprio S, Rosaria Umano G, Pierpont B, Nouws J, Galderisi A, Kim G, Mata MM, Santoro N. Metabolic Features of Nonalcoholic Fatty Liver (NAFL) in Obese Adolescents: Findings From a Multiethnic Cohort. Hepatology. 2018 Oct;68(4):1376-1390. doi: 10.1002/hep.30035.
Other Identifiers
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1104008388
Identifier Type: -
Identifier Source: org_study_id