Trial record 1 of 1 for:
NCT02513121
Dietary Treatment Study of Pediatric NAFLD (DTS)
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| ClinicalTrials.gov Identifier: NCT02513121 |
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Recruitment Status :
Completed
First Posted : July 31, 2015
Last Update Posted : January 11, 2018
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Sponsor:
University of California, San Diego
Collaborators:
Emory University
Nutrition Science Initiative
Information provided by (Responsible Party):
Jeffrey B. Schwimmer, MD, University of California, San Diego
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Brief Summary:
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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Non-alcoholic fatty liver disease
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Dietary modification
Low free sugar diet
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Other: Dietary modification
The intervention is a modification of the family's habitual diet with a low sugar version of their diet. |
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No Intervention: Observational Arm
Standard of care
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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 ]
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| 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
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): NCT02513121
Locations
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92093 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
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 |
Publications:
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 History of Changes |
| Other Study ID Numbers: |
2015-4405 |
| First Posted: | July 31, 2015 Key Record Dates |
| Last Update Posted: | January 11, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Jeffrey B. Schwimmer, MD, University of California, San Diego:
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NAFLD Steatohepatitis NASH Liver |
Diet Pediatric Adolescent |
Additional relevant MeSH terms:
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Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |