Clinical trial
Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
Recruiting now · Not applicable · 1 countries · Registry ID NCT04634643
Recruiting nowNot applicableObservational
What this study is about
The main aim of the study is to discover the mechanisms underlying the pathophysiology of NAFLD in obese youth.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age12 Years to 18 Years
SexAll
Healthy volunteersNot listed
ConditionNAFLD
Full registry criteria
Inclusion Criteria: * Good general health, taking no medication on a chronic basis; * age 12 to 18 years, in puberty (girls and boys: Tanner stage II-V); * BMI \>85th for obese cohort; Exclusion Criteria: * Baseline creatinine \>1.0 mg; pregnancy; * the presence of endocrinopathies (e.g. Cushing syndrome); * cardiac or pulmonary or other significant chronic illness; * adolescents with a psychiatric disorder or with substance abuse; * monogenic obesity syndromes; * use of drugs affecting intrahepatic fat content (e.g.; liraglutide, fish oil, etc.).
Treatments and study arms
Usual diet and physical activity
Other
Patients will be followed up to assess the effect of the usual diet and physical activity on development of NAFLD
Primary outcomes
Lactate synthesis60 months
lactate synthesis will be measured during an oral glucose tolerance test by measuring lactate. Synthetic rates will be measured by using a mathematical model.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Yale New Haven Hospital🇺🇸 New Haven, Connecticut, United States
Ermena RefugjatiContact
Nicola Santoro, MD, PhDPrincipal Investigator