Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) (TONIC)
Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
研究概览
研究类型
介入性
注册 (实际的)
173
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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San Diego、California、美国、92103
- University of California, San Diego
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San Francisco、California、美国、94143
- University of California, San Francisco
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District of Columbia
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Washington、District of Columbia、美国、20010
- Children's National Medical Center
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins University
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Missouri
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St. Louis、Missouri、美国、63110
- St. Louis University
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Ohio
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Cleveland、Ohio、美国、44109
- Case Western Reserve University
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Texas
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Houston、Texas、美国、77030
- Texas Children's Hospital
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Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University
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Washington
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Seattle、Washington、美国、98195
- University of Washington
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
- Age 8-17 years at first screening visit
- Histologic evidence of Nonalcoholic Fatty Liver Disease (NAFLD) - biopsy cannot be older than 6 months as of randomization
- ALT level >60 U/L at time of screening and on one previous occasion determined at least one month but no greater than 6 months prior to screening ALT
- Consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：3
Matching placebo
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Twice daily
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有源比较器：1
Metformin, 500 mg, twice daily
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500 mg, twice daily
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有源比较器：2
Vitamin E, 400 IU, twice daily
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400 IU, twice daily
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L
大体时间：baseline and 96 weeks
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The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.
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baseline and 96 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Serum Aspartate Aminotransferase (AST)
大体时间：baseline and 96 weeks
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baseline and 96 weeks
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Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment
大体时间：baseline and 96 weeks
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Histological activity was assessed using the NAFLD activity score on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (0-3), lobular inflammation (0-3), and hepatocellular ballooning (0-2).
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baseline and 96 weeks
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Number of Participants With Improvement in Liver Fibrosis Score
大体时间：baseline and 96 weeks
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Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.
This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score at 96 weeks compared to baseline, which indicates improvement in fibrosis.
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baseline and 96 weeks
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Number of Participants With Improvement in Steatosis Score
大体时间：baseline and 96 weeks
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Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis.
This secondary outcome measure is the number of participants that experienced a decrease in steatosis score at 96 weeks compared to baseline, which indicates improvement in steatosis.
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baseline and 96 weeks
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Number of Participants With Improvement in Lobular Inflammation Score
大体时间：baseline and 96 weeks
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Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation.
This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score at 96 weeks compared to baseline, which indicates improvement in lobular inflammation.
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baseline and 96 weeks
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Number of Participants With Improvement in Ballooning Degradation Score
大体时间：baseline and 96 weeks
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Ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe ballooning.
This secondary outcome measure is the number of participants that experienced a decrease in ballooning score at 96 weeks compared to baseline, which indicates improvement in ballooning.
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baseline and 96 weeks
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Change in Body Mass Index
大体时间：baseline and 96 weeks
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baseline and 96 weeks
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Change in Serum Vitamin E Levels
大体时间：baseline and 96 weeks
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Change in alpha-Tocopherol
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baseline and 96 weeks
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Change in Quality of Life (QOL) Scores- Physical Health
大体时间：baseline and 96 weeks
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Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.
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baseline and 96 weeks
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Change in QOL- Psychosocial Health
大体时间：baseline and 96 weeks
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Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.
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baseline and 96 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Guerrerio AL, Colvin RM, Schwartz AK, Molleston JP, Murray KF, Diehl A, Mohan P, Schwimmer JB, Lavine JE, Torbenson MS, Scheimann AO. Choline intake in a large cohort of patients with nonalcoholic fatty liver disease. Am J Clin Nutr. 2012 Apr;95(4):892-900. doi: 10.3945/ajcn.111.020156. Epub 2012 Feb 15.
- Corey KE, Vuppalanchi R, Vos M, Kohli R, Molleston JP, Wilson L, Unalp-Arida A, Cummings OW, Lavine JE, Chalasani N; Nonalcoholic Steatohepatitis Clinical Research Network. Improvement in liver histology is associated with reduction in dyslipidemia in children with nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):360-7. doi: 10.1097/MPG.0000000000000584.
- Lavine JE, Schwimmer JB, Van Natta ML, Molleston JP, Murray KF, Rosenthal P, Abrams SH, Scheimann AO, Sanyal AJ, Chalasani N, Tonascia J, Unalp A, Clark JM, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; Nonalcoholic Steatohepatitis Clinical Research Network. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents: the TONIC randomized controlled trial. JAMA. 2011 Apr 27;305(16):1659-68. doi: 10.1001/jama.2011.520.
- Lavine JE, Schwimmer JB, Molleston JP, Scheimann AO, Murray KF, Abrams SH, Rosenthal P, Sanyal AJ, Robuck PR, Brunt EM, Unalp A, Tonascia J; Nonalcoholic Steatohepatitis Clinical Research Network Research Group. Treatment of nonalcoholic fatty liver disease in children: TONIC trial design. Contemp Clin Trials. 2010 Jan;31(1):62-70. doi: 10.1016/j.cct.2009.09.001. Epub 2009 Sep 15.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年9月1日
初级完成 (实际的)
2009年9月1日
研究完成 (实际的)
2010年2月1日
研究注册日期
首次提交
2003年7月1日
首先提交符合 QC 标准的
2003年7月2日
首次发布 (估计)
2003年7月3日
研究记录更新
最后更新发布 (估计)
2012年9月27日
上次提交的符合 QC 标准的更新
2012年8月27日
最后验证
2012年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Metformin的临床试验
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Poznan University of Medical SciencesUniversity of California, San Diego未知
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Boehringer IngelheimEli Lilly and Company完全的
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Boehringer IngelheimEli Lilly and Company完全的