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

NCT01930123 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-08-31

Study results available
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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.

Conditions

  • Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

DRUG

intravenous fructose challenge

Patients will be admitted to our Duke Clinical Research Unit (DCRU) at least 12 hours prior to morning intravenous fructose challenge. All patients will have a "standard" meal in order to control for dietary composition and calorie intake prior to intravenous fructose challenge. Patients will be NPO (nothing by mouth) after midnight for morning IV fructose MR biomarker measures. Patients with suspected NAFLD will have had an historical standard of care liver biopsy in the past and will have IV fructose Magnetic Resonance biomarker measures in the morning.

OTHER

Blood Draw

Fasting bloodwork will be obtained before and after the IV fructose challenge.

Sponsors & Collaborators

  • Manal F Abdelmalek

    lead OTHER

Principal Investigators

  • Manal F Abdelmalek, MD., MPH · DUMC - Gastroenterology

  • Brian Soher, PhD · DUMC -Radiology

  • Mustafa Bashir, MD · DUMC - Radiology

  • Cynthia Guy, MD · DUMC- Pathology

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930123 on ClinicalTrials.gov