The Role of Hepatic De Novo Lipogenesis (DNL) in the Pathogenesis of Hepatic Steatosis
- Study HIC#:1604017607
- Last Updated:02/25/2024
Why are they doing this study?
Being overweight and having too much fat in your liver isn’t good for you, so doctors need to study why this takes place so they can figure out how to treat it. We want to test whether de novo lipogenesis (DNL), which is the process by which fat is obtained by dietary intake of carbohydrates, is enhanced after consumption of a high carbohydrate meal and if this might be a consequence of the production from the gut bacteria of some molecules called short chain fatty acids. The short chain fatty acids are good for us, but when produced in excess they can increase the production of fat in the liver and cause obesity and fatty liver. So, we want to see how your body is handling the carbohydrates that you eat while you are here for the study.
- Age12 years - 30 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Erin Weidman
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
a) To examine whether hepatic de novo lipogenesis (DNL) during consumption of high carbohydrate meals is increased in obese youngsters with hepatic steatosis compared to age, ethnicity and obesity matched controls without fatty liver. b) To assess the role of short chain fatty acids derived from the gut microbiota in modulating body fat partition in obese children and adolescents.
Eligibility Criteria
Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion? How will eligibility be determined, and by whom?
Overweight will be defined as a BMI between the 75th and 95th percentiles specific for age and gender, and obese will be defined as a BMI greater than the 95th percentile. Following the screening oral glucose tolerance test (OGTT, 75 gm) (HIC #11190), subjects will be classified as normal glucose tolerant if plasma glucose at two hours is <140 mg/dl and as impaired glucose tolerant if plasma glucose is ≥140 mg/dl. To enter the study all subjects must be in good general health, have a normal medical history and physical exam, and have no endocrinopathies (normal thyroid function test) or other diseases that might affect glucose metabolism. They will not be on any medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Celexa, Lithium and Paxil. Eligibility will be determined by a comprehensive family and medical history and physical examination prior to enrollment in the study.
The two groups of obese subjects will be diagnosed with (cases) and without hepatic steatosis (controls) by the abdominal MRI. In particular:
Cases will meet the following criteria:
- Age between 12 and 30 years
- 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:
- Age between 12 and 30 years
- 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
