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Dietary Treatment Study of Pediatric NAFLD (DTS)

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary modification
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring NAFLD, Steatohepatitis, Nonalcoholic Steatohepatitis (NASH), Liver, Diet, Pediatric, Adolescent

Eligibility Criteria

11 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Boys age 11-16 years inclusive.
  • Clinical history consistent with NAFLD.
  • Biopsy-proven NAFLD
  • MRI measured Liver Proton Density Fat Fraction ≥10%
  • alanine aminotransferase (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 (Alcohol Use Disorders Identification Test [AUDIT]) 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

Sites / Locations

  • University of California, San Diego
  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Dietary modification

Observational Arm

Arm Description

Low free sugar diet

Standard of care

Outcomes

Primary Outcome Measures

Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (<3%) in boys with NAFLD will change liver fat % measured by MRI.

Secondary Outcome Measures

Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Change in Insulin From Baseline to Week 8
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Change in Triglycerides From Baseline to Week 8

Full Information

First Posted
July 29, 2015
Last Updated
January 16, 2020
Sponsor
University of California, San Diego
Collaborators
Emory University, Nutrition Science Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT02513121
Brief Title
Dietary Treatment Study of Pediatric NAFLD
Acronym
DTS
Official Title
Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Emory University, Nutrition Science Initiative

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an investigator initiated study being conducted in equal numbers at two sites, University of California, San Diego (UC San Diego) and Emory University (EU). 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 magnetic resonance imaging (MRI) testing to measure liver fat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease
Keywords
NAFLD, Steatohepatitis, Nonalcoholic Steatohepatitis (NASH), Liver, Diet, Pediatric, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary modification
Arm Type
Active Comparator
Arm Description
Low free sugar diet
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Other
Intervention Name(s)
Dietary modification
Intervention Description
The intervention is a modification of the family's habitual diet with a low sugar version of their diet.
Primary Outcome Measure Information:
Title
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
Description
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (<3%) in boys with NAFLD will change liver fat % measured by MRI.
Time Frame
Measurements done at baseline and week 8.
Secondary Outcome Measure Information:
Title
Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Time Frame
Measurements done at baseline and week 8
Title
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Time Frame
Measurements doen at baseline and week 8
Title
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Time Frame
Measurements done at baseline and week 8
Title
Change in Insulin From Baseline to Week 8
Time Frame
Measurements done at baseline and week 8
Title
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
Description
HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Time Frame
Measurements done at baseline and week 8
Title
Change in Triglycerides From Baseline to Week 8
Time Frame
Measurements done at baseline and week 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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% alanine aminotransferase (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 (Alcohol Use Disorders Identification Test [AUDIT]) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey B Schwimmer, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miriam Vos, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data will be made available in response to bona fide and good faith, ad hoc requests. Suitability of each request, if consistent with Institutional Review Board (IRB) approval, will be determined only in the case of a favorable vote of a majority of a committee consisting of each consortium investigator and the Grantor. Data will be made available with a signed access agreement.
Citations:
PubMed Identifier
14571229
Citation
Schwimmer JB, Deutsch R, Rauch JB, Behling C, Newbury R, Lavine JE. Obesity, insulin resistance, and other clinicopathological correlates of pediatric nonalcoholic fatty liver disease. J Pediatr. 2003 Oct;143(4):500-5. doi: 10.1067/S0022-3476(03)00325-1.
Results Reference
background
PubMed Identifier
17015527
Citation
Schwimmer JB, Deutsch R, Kahen T, Lavine JE, Stanley C, Behling C. Prevalence of fatty liver in children and adolescents. Pediatrics. 2006 Oct;118(4):1388-93. doi: 10.1542/peds.2006-1212.
Results Reference
background
PubMed Identifier
18591439
Citation
Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular risk factors and the metabolic syndrome in pediatric nonalcoholic fatty liver disease. Circulation. 2008 Jul 15;118(3):277-83. doi: 10.1161/CIRCULATIONAHA.107.739920. Epub 2008 Jun 30.
Results Reference
background
PubMed Identifier
22544914
Citation
Jin R, Le NA, Liu S, Farkas Epperson M, Ziegler TR, Welsh JA, Jones DP, McClain CJ, Vos MB. Children with NAFLD are more sensitive to the adverse metabolic effects of fructose beverages than children without NAFLD. J Clin Endocrinol Metab. 2012 Jul;97(7):E1088-98. doi: 10.1210/jc.2012-1370. Epub 2012 Apr 27.
Results Reference
background
PubMed Identifier
25111123
Citation
Jin R, Welsh JA, Le NA, Holzberg J, Sharma P, Martin DR, Vos MB. Dietary fructose reduction improves markers of cardiovascular disease risk in Hispanic-American adolescents with NAFLD. Nutrients. 2014 Aug 8;6(8):3187-201. doi: 10.3390/nu6083187.
Results Reference
background
PubMed Identifier
25529941
Citation
Schwimmer JB, Middleton MS, Behling C, Newton KP, Awai HI, Paiz MN, Lam J, Hooker JC, Hamilton G, Fontanesi J, Sirlin CB. Magnetic resonance imaging and liver histology as biomarkers of hepatic steatosis in children with nonalcoholic fatty liver disease. Hepatology. 2015 Jun;61(6):1887-95. doi: 10.1002/hep.27666. Epub 2015 Feb 5.
Results Reference
background
PubMed Identifier
26203597
Citation
Jin R, Vos MB. Fructose and liver function--is this behind nonalcoholic liver disease? Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):490-5. doi: 10.1097/MCO.0000000000000203.
Results Reference
background
PubMed Identifier
34907907
Citation
Cohen CC, Li KW, Alazraki AL, Beysen C, Carrier CA, Cleeton RL, Dandan M, Figueroa J, Knight-Scott J, Knott CJ, Newton KP, Nyangau EM, Sirlin CB, Ugalde-Nicalo PA, Welsh JA, Hellerstein MK, Schwimmer JB, Vos MB. Dietary sugar restriction reduces hepatic de novo lipogenesis in adolescent boys with fatty liver disease. J Clin Invest. 2021 Dec 15;131(24):e150996. doi: 10.1172/JCI150996.
Results Reference
derived
PubMed Identifier
30667502
Citation
Schwimmer JB, Ugalde-Nicalo P, Welsh JA, Angeles JE, Cordero M, Harlow KE, Alazraki A, Durelle J, Knight-Scott J, Newton KP, Cleeton R, Knott C, Konomi J, Middleton MS, Travers C, Sirlin CB, Hernandez A, Sekkarie A, McCracken C, Vos MB. Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial. JAMA. 2019 Jan 22;321(3):256-265. doi: 10.1001/jama.2018.20579. Erratum In: JAMA. 2019 Aug 6;322(5):469.
Results Reference
derived

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Dietary Treatment Study of Pediatric NAFLD

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