DNL
The Role of Hepatic De Novo Lipogenesis (DNL) in the Pathogenesis of Hepatic Steatosis in Obese Children and Adolescents
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · American Heart Association
observational
60
1 country
1
Study Start
December 2010
Actual (reported)Primary Completion
August 10, 2022
Actual (reported)Study Completion
August 10, 2022
Actual (reported)Nonalcoholic Fatty Liver Disease (NAFLD) is becoming the most common cause of liver disease in pediatrics, but little is known about its pathophysiology in children. While studies in obese adults with hepatic steatosis have described an increased hepatic de novo lipogenesis (DNL) depending on the diet, there are no studies exploring the mechanisms by which excess hepatic triglycerides increases in obese youths, thus explaining the accompanying dyslipidemia and the metabolic syndrome. The central hypothesis of this study is that hepatic conversion of carbohydrates to lipid (DNL) is enhanced and associated with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese youths with hepatic steatosis. The overall goal is to examine whether hepatic DNL is increased in obese youths with steatosis compared to matched controls without steatosis. Hypotheses: Hepatic conversion of carbohydrates to lipid (DNL) is enhanced and is associated with accumulation of excess liver fat, dyslipidemia and hepatic insulin resistance in obese youths with hepatic steatosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 10, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2010
Actual (reported)October 30, 2012
Actual (reported)November 12, 2012
Actual (reported)August 10, 2022
Actual (reported)August 10, 2022
Actual (reported)de novo lipogenesis response to high carbohydrate meal in obese kids with fatty liver
Study visit 3
de novo lipogenesis response to high carbohydrate meal in obese kids without fatty liver
Study visit 3
The majority of the research subjects will be recruited from the Yale Pediatric Obesity Clinic and the Endocrine Clinic. Following the oral glucose tolerance test (OGTT):normal glucose tolerant if plasma glucose at two hours is \<140 mg/dl and impaired glucose tolerant if plasma glucose is ≥140 mg/dl. All subjects must be in good general health, have a normal medical history and physical exam, and have no endocrinopathies or other diseases that might affect glucose metabolism. They will not be on any medications that are known to alter glucose or insulin metabolism or certain psychiatric medications. Subjects determined to be eligible will receive a MRI to determine Hepatic Fat Content. Subjects will agree to genetic testing to determine genotype.
Yale University
New Haven, Connecticut, 06510, United States
Serum
Sonia Caprio, M.D.
Yale University
Nicola Santoro, M.D./Ph.D,
Yale University
60 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2012
First Posted
November 12, 2012
Study Start
December 2010
Actual (reported)Insulin Resistance in Non-alcoholic Fatty Liver Disease
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Contact the study team to confirm eligibility.
Primary Completion
August 10, 2022
Actual (reported)Study Completion
August 10, 2022
Actual (reported)Last Updated
June 15, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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