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Trial record 1 of 2 for:    schwimmer
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Dietary Treatment Study of Pediatric NAFLD (DTS)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Jeffrey B. Schwimmer, MD, University of California, San Diego
Sponsor:
Collaborators:
Emory University
Nutrition Science Initiative
Information provided by (Responsible Party):
Jeffrey B. Schwimmer, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02513121
First received: July 29, 2015
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
This is an investigator initiated study being conducted in equal numbers at two sites, UC San Diego and Emory University. The purpose of this study is to understand the potential of a low sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect of this dietary change will be assessed using advanced MRI testing to measure liver fat.

Condition Intervention
Nonalcoholic Fatty Liver Disease Other: Dietary modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD

Resource links provided by NLM:


Further study details as provided by Jeffrey B. Schwimmer, MD, University of California, San Diego:

Primary Outcome Measures:
  • Change of fat in the liver measured by proton density fat fraction (PDFF) [ Time Frame: Eight (8) weeks ]
    To evaluate change in liver fat over 8 weeks in response to a low sugar diet in children with NAFLD.


Secondary Outcome Measures:
  • Change in alanine aminotransferase (ALT) [ Time Frame: Eight (8) weeks ]
  • Change in aspartate aminotransferase (AST) [ Time Frame: Eight (8) weeks ]
  • Change in gamma-glutamyl transferase (GGT) [ Time Frame: Eight (8) weeks ]
  • Change in weight [ Time Frame: Eight (8) weeks ]
  • Change in body mass index (BMI) [ Time Frame: Eight (8) weeks ]
  • Change in waist circumference [ Time Frame: Eight (8) weeks ]

Estimated Enrollment: 40
Study Start Date: July 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary modification
Low free sugar diet
Other: Dietary modification
The intervention is a modification of the family's habitual diet with a low sugar version of their diet.
No Intervention: Observational Arm
Standard of care

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Boys age 11-16 years inclusive.
  • Clinical history consistent with NAFLD.
  • Biopsy-proven NAFLD
  • MRI measured Liver Proton Density Fat Fraction ≥10%
  • ALT ≥ 45 u/L
  • No evidence of any other liver disease by clinical history or histological evaluation.
  • Written informed consent from parent or legal guardian.
  • Written informed assent from the child or adolescent.

Exclusion Criteria:

Exclusions will not be based upon gender, race, or ethnicity. Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators will be excluded from the study:

  • History of significant alcohol intake (AUDIT questionnaire) or inability to quantify alcohol consumption
  • Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis in the past year.
  • The use of other known hepatotoxins within 120 days of baseline
  • History of total parenteral nutrition (TPN) use in the year prior to screening
  • History of bariatric surgery or planning to undergo bariatric surgery during the study duration
  • Significant depression
  • Non-compensated liver disease with any one of the following hematologic, biochemical, and serological criteria on entry into protocol:
  • Hemoglobin < 10 g/dL
  • White blood cell < 3,500 cells/mm
  • Neutrophil count < 1,500 cells/mm3 of blood
  • Platelets < 130,000 cells/mm3 of blood
  • Direct bilirubin > 1.0 mg/dL
  • Total bilirubin > 3 mg/dL
  • Albumin < 3.2 g/dL
  • International normalized ratio (INR) > 1.4
  • Evidence of other chronic liver disease
  • Children who are currently enrolled in a clinical trial or who received an investigational study drug or a medication with the intent to treat NAFLD/NASH in the past 60 days
  • Contraindications to MRI, e.g. metal in the eyes, implanted electronic devices, aneurysm clips, pacemaker, cochlear implants
  • Unable to have or complete the MRI exam due to body weight exceeding scanner table limit or girth exceeding scanner bore diameter
  • Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
  • Families with > 5 individuals
  • Failure to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02513121

Contacts
Contact: Janis Durelle, BS 619-543-5226 jdurelle@ucsd.edu
Contact: Patricia A Ugalde Nicalo, MD 619-543-7673 pugaldenicalo@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Janis Durelle, BS    619-543-5226    jdurelle@ucsd.edu   
Contact: Patricia A Ugalde Nicalo, MD    619-543-7673    pugaldenicalo@ucsd.edu   
Principal Investigator: Jeffrey B Schwimmer, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rebecca Cleaton, MPH    404-727-5383    rebecca.cleeton@choa.org   
Contact: Maria Codero, BS    404-727-5383    mcorder@emory.edu   
Principal Investigator: Miriam Vos, MD         
Sponsors and Collaborators
University of California, San Diego
Emory University
Nutrition Science Initiative
Investigators
Principal Investigator: Jeffrey B Schwimmer, MD University of California, San Diego
Principal Investigator: Miriam Vos, MD Emory University
  More Information

Publications:

Responsible Party: Jeffrey B. Schwimmer, MD, Professor of Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02513121     History of Changes
Other Study ID Numbers: 2015-4405
Study First Received: July 29, 2015
Last Updated: May 10, 2016

Keywords provided by Jeffrey B. Schwimmer, MD, University of California, San Diego:
NAFLD
Steatohepatitis
NASH
Liver
Diet
Pediatric
Adolescent

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases

ClinicalTrials.gov processed this record on August 23, 2017