Hepatic De Novo Lipogenesis (DNL)in the Pathogenesis of Hepatic Steatosis in Obese Youth (NCT01725035) | Clinical Trial Compass
CompletedNot Applicable
Hepatic De Novo Lipogenesis (DNL)in the Pathogenesis of Hepatic Steatosis in Obese Youth
United States60 participantsStarted 2010-12
Plain-language summary
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.
Who can participate
Age range
12 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cases will meet the following criteria:
* BMI higher than 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) greater or equal than 5.5%
* Absence of any endocrinopathy
* Absence of any therapy with medication known to alter glucose metabolism
Controls will meet the following criteria:
* BMI higher than 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) lower than 5.5%
* Absence of any endocrinopathy
* Absence of any therapy with medication known to alter glucose metabolism
* Absence of any therapy with medication known to alter glucose metabolism
Exclusion Criteria:
* BMI under the 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) less than 5.5%
* Absence of any endocrinopathy
* Any therapy with medication known to alter glucose metabolism
Controls will meet the following criteria:
* BMI under the 75th percentile
* Hepatic fat fraction (the amount of fat into the liver) greater than or equal to 5.5%
* Any endocrinopathy
* Any therapy with medication known to alter glucose metabolism
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
de novo lipogenesis response to high carbohydrate meal in obese kids with fatty liver