Dietary Treatment Study of Pediatric NAFLD (DTS)
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ClinicalTrials.gov Identifier: NCT02513121 |
Recruitment Status :
Completed
First Posted : July 31, 2015
Results First Posted : January 28, 2020
Last Update Posted : January 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nonalcoholic Fatty Liver Disease | Other: Dietary modification | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD |
Study Start Date : | July 2015 |
Actual Primary Completion Date : | August 31, 2017 |
Actual Study Completion Date : | August 31, 2017 |

Arm | Intervention/treatment |
---|---|
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
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- Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group [ Time Frame: Measurements done at baseline and week 8. ]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.
- Change in Alanine Aminotransferase (ALT) From Baseline to Week 8 [ Time Frame: Measurements done at baseline and week 8 ]
- Change in Aspartate Aminotransferase (AST) From Baseline to Week 8 [ Time Frame: Measurements doen at baseline and week 8 ]
- Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8 [ Time Frame: Measurements done at baseline and week 8 ]
- Change in Insulin From Baseline to Week 8 [ Time Frame: Measurements done at baseline and week 8 ]
- Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8 [ Time Frame: Measurements done at baseline and 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 [ Time Frame: Measurements done at baseline and week 8 ]

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

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): NCT02513121
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92093 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Jeffrey B Schwimmer, MD | University of California, San Diego | |
Principal Investigator: | Miriam Vos, MD | Emory University |
Documents provided by Jeffrey B. Schwimmer, MD, University of California, San Diego:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jeffrey B. Schwimmer, MD, Professor of Pediatrics, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02513121 |
Other Study ID Numbers: |
2015-4405 |
First Posted: | July 31, 2015 Key Record Dates |
Results First Posted: | January 28, 2020 |
Last Update Posted: | January 28, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
NAFLD Steatohepatitis Nonalcoholic Steatohepatitis (NASH) Liver |
Diet Pediatric Adolescent |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |