Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance (MR) Biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD)

Who is this study for? Patients with nonalcoholic fatty liver disease
What treatments are being studied? Intravenous fructose challenge
Status: Terminated
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for imaging in liver in both a cross-sectional and a longitudinal dietary intervention study of patients with Nonalcoholic Fatty Liver Disease (NAFLD), 3) create a liver tissue bank with correlative imaging data, 4) develop reliable non-invasive MR markers to distinguish simple steatosis from Nonalcoholic Steatohepatitis (NASH), and 5) define the dynamic changes in metabolism, energy homeostasis, and MR biomarkers as they relate to fructose-related liver injury.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

∙ Patients must satisfy all of the following criteria to be eligible for enrollment:

• Age greater than 18 years as of the initial screening interview and provision of consent

• Healthy control as defined by:

‣ normal liver aminotransferases AND

⁃ no evidence of NAFLD on radiologic imaging studies AND

⁃ no history of chronic liver disease OR

⁃ liver biopsy (if one had been historically performed for evaluation of suspected liver disease).

∙ OR • Patient with clinically suspected NAFLD as assessed by standard of care measures (risk factors for NAFLD, abnormal liver enzymes and/or fatty liver on imaging studies) who are scheduled to will undergo liver biopsy for the purpose of grading / staging the severity of their underlying liver disease

Locations
United States
North Carolina
Duke University Medical Center
Durham
Time Frame
Start Date: 2013-10
Completion Date: 2020-01
Participants
Target number of participants: 118
Treatments
Experimental: Patients with NAFLD
70 subjects with biopsy-proven NAFLD; subjects will be challenged with a fructose infusion after a period for 12 hours fasting.
Active_comparator: Health controls
15 healthy controls for comparison with NAFLD patients.The 15 subjects will be challenged with a fructose infusion after a period for 12 hours fasting.
Authors
Mustafa Bashir, Manal F Abdelmalek
Related Therapeutic Areas
Sponsors
Leads: Manal F Abdelmalek

This content was sourced from clinicaltrials.gov