Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
ConditionNAFLD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorYale University
About this trial
The main aim of the study is to discover the mechanisms underlying the pathophysiology of NAFLD in obese youth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Hispanics and NHB youth with and without NAFLD
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Usual diet and physical activity
Other interventionPatients will be followed up to assess the effect of the usual diet and physical activity on development of NAFLD
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Lactate synthesis
lactate synthesis will be measured during an oral glucose tolerance test by measuring lactate. Synthetic rates will be measured by using a mathematical model.
Time frame
60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov