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Impact of Fructose on Metabolism, Energy Homeostasis and MR Biomarkers in NAFLD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01930123
Recruitment Status : Recruiting
First Posted : August 28, 2013
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Manal Abdelmalek, Duke University

Brief 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 NAFLD, 3) create a liver tissue bank with correlative imaging data, 4) develop reliable non-invasive MR markers to distinguish simple steatosis from NASH, and 5) define the dynamic changes in metabolism, energy homeostasis, and MR biomarkers as they relate to fructose-related liver injury.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease (NAFLD) Drug: intravenous fructose challenge Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Fructose on Metabolism, Energy Homeostasis and MR Biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD)
Study Start Date : October 2013
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
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.
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 after midnight for morning IV fructose MR biomarker measures. Patients with suspected NAFLD will have a standard of care , liver biopsy followed by , and co-localization of liver biopsy with MR.

Placebo Comparator: Health controls
15 healthy controls for comparison with NALFD patients.The 15 subjects will be challenged with a fructose infusion after a period for 12 hours fasting.
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 after midnight for morning IV fructose MR biomarker measures. Patients with suspected NAFLD will have a standard of care , liver biopsy followed by , and co-localization of liver biopsy with MR.




Primary Outcome Measures :
  1. Change in metabolism [ Time Frame: baseline, one hour, 4 hours, 24 hours, and normalization of the study parameters (up to 3 days) ]
    Exploratory study to evaluate the acute (baseline and dynamic) changes in metabolism and in energy homeostatic in volunteers and patients with biopsy-proven NAFLD measures following IV challenge and dietary fructose restriction.

  2. Change in energy homeostatic [ Time Frame: baseline, one hour, 4 hours, 24 hours, and normalization of the study parameters (up to 3 days) ]
    Exploratory study to evaluate the acute (baseline and dynamic) changes in metabolism and in energy homeostatic in volunteers and patients with biopsy-proven NAFLD measures following IV challenge and dietary fructose restriction.


Secondary Outcome Measures :
  1. Change in MR Biomarkers [ Time Frame: baseline, one hour, 4 hours, 24 hours, and normalization of the study parameters (up to 3 days) ]
    Exploratory study to evaluate the acute (baseline and dynamic) changes MR biomarkers in volunteers and patients with biopsy-proven NAFLD measures following IV challenge and dietary fructose restriction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment:

  • Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average)
  • Inability to reliably quantify alcohol consumption based upon local study physician judgment
  • Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the past year prior to randomization
  • Prior or planned (during the study period) bariatric surgery
  • Uncontrolled diabetes defined as HbA1c 9.5% or higher within 60 days prior to enrollment
  • A platelet count below 90,000/mm3
  • Clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities:

    • Serum albumin greater than 3.2 g/dL, INR greater than 1.3, bilirubin greater than 2.0 mg/dL
    • History of esophageal varices, ascites or hepatic encephalopathy
  • Evidence of other forms of chronic liver disease
  • Serum alanine aminotransferase (ALT) greater than 300 U/L
  • Serum creatinine of 2.0 mg/dL or greater
  • Unstable therapy for components of the metabolic syndrome (ie. recent starting or stopping of insulin sensitizing agent, lipid lowering agent, and/or antioxidant therapy) . Recent starting or stopping (for more than 7 days) the use of a thiazolidinedione (pioglitazone or rosiglitazone) 90 days before the entry biopsy or anytime thereafter
  • Use of any prescription or over-the-counter medication or herbal remedy that are believed to improve or treat NASH or liver disease or obesity for the 90 days prior to baseline liver biopsy or prior to randomization

    - Patients must not take any other agent to treat NASH except the treatment assigned after randomization.

  • Inability to safely obtain a liver biopsy
  • Active substance abuse including inhaled or injection drugs in the year prior to screening
  • Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
  • Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
  • A contraindication to MRI examinations
  • Extreme claustrophobia
  • Weight or girth exceeds the scanner capabilities
  • Any condition or circumstance that, in the opinion of the site investigator, would interfere with completion of MR examinations
  • Failure to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930123


Contacts
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Contact: Mari Kopping, MS, RD 919.684.4798 mariko.kopping@duke.edu
Contact: Stephanie Buie 919.684.4138 stephanie.buie@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Mari Kopping, MS, RD    919-684-4798    mariko.kopping@duke.edu   
Contact: Stephanie Buie    919.684.4138    stephanie.buie@duke.edu   
Principal Investigator: Manal F Abdelmalek, MD., MPH         
Sub-Investigator: Brian J Soher, PhD         
Sub-Investigator: Mustafa Bashir, MD.         
Sub-Investigator: Cynthia Guy, MD         
Sponsors and Collaborators
Manal Abdelmalek
Investigators
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Principal Investigator: Manal F Abdelmalek, MD., MPH DUMC - Gastroenterology
Principal Investigator: Brian Soher, PhD DUMC -Radiology
Principal Investigator: Mustafa Bashir, MD DUMC - Radiology
Principal Investigator: Cynthia Guy, MD DUMC- Pathology
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Responsible Party: Manal Abdelmalek, Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT01930123    
Other Study ID Numbers: Pro00031687
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by Manal Abdelmalek, Duke University:
Fructose
NASH
advanced fibrosis
biomarker
magnetic resonance
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases