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NCT02358928 · ClinicalTrials.gov registry record · NA
Low Carbohydrate Diet: The Effects on Non Alcoholic Fatty Liver Disease in Obese Teens With Metabolic Syndrome
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02358928: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT02358928 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02358928, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Concurrent with the rising prevalence of childhood obesity, the co-morbid condition of non-alcoholic fatty liver disease (NAFLD) has become the leading cause of chronic liver disease among children. NAFLD is characterized by accrual of excess triglycerides (TG) in the liver that leads to inflammation, fibrosis, and cirrhosis. One-third of the pediatric population has NAFLD, a disease strongly associated with insulin-resistance and metabolic-syndrome (Met-S). NAFLD is predicted to become the leading cause of liver transplantation in adults by 2030. Current understanding of NAFLD indicates that presence of excess TG in liver is an absolute requirement for disease progression. First-line therapy for NAFLD is focused on decreasing adiposity and improving insulin sensitivity through diet and exercise. Recent adult data indicate that dietary carbohydrate-restriction is more effective at reducing hepatic TG-content than traditional calorie-restriction. Few studies have been conducted to establish resolution of hepatic steatosis by any intervention. Such studies in pediatrics are primarily limited by a need for liver biopsy. However, hepatic proton magnetic resonance spectroscopy (H-MRS) is a new innovative tool used to quantitatively measure hepatic TG content in a non-invasive manner. The primary aim is to compare the impact of dietary weight loss via carbohydrate-restriction and calorie-restriction on hepatic TG-content quantified by H-MRS in obese children with biopsy-proven NAFLD and Met-S. This IRB approved protocol is a randomized control study. The investigators will recruit subjects from the Center for Obesity and its Consequences in Health and the pediatric gastroenterology clinics between the ages of 11-17 years who meet criteria for NAFLD and Met-S. A H-MRS will be obtained in each subject prior to the start of dietary intervention. Fifty-four subjects will be randomized to either a carbohydrate-restricted or calorie-restricted diet for 6 months with no chang
Primary Outcome
To compare the impact of dietary weight loss via carbohydrate-restriction and calorie-restriction on hepatic TG content quantified by H-MRS in obese children with biopsy-proven NAFLD and Met-S.
Interventions
- OTHER Diet Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-08-18 |
| Phase | NA |
What the finished NCT02358928 record still lists
NCT02358928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Diet Intervention is the first listed.
NCT02358928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02358928 about?
NCT02358928 is a clinical study titled "Low Carbohydrate Diet: The Effects on Non Alcoholic Fatty Liver Disease in Obese Teens With Metabolic Syndrome". Concurrent with the rising prevalence of childhood obesity, the co-morbid condition of non-alcoholic fatty liver disease (NAFLD) has become the leading cause of chronic liver disease among children. NAFLD is characterized by accrual of excess triglycerides (TG) in the liver that leads to inflammatio...
What is the current status of trial NCT02358928?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2014-07. Estimated completion is 2016-08-18.
What interventions are being tested in trial NCT02358928?
The interventions under investigation include: Diet Intervention (OTHER).
Who is sponsoring clinical trial NCT02358928?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02358928's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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