Weight Management in Nonalcoholic Steatohepatitis
Weight Management in Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases.
The cause of NASH is not completely understood and currently there is no effective treatment for this disease.
An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis.
Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management.
However, there are very limited data on the efficacy of weight reduction as a treatment for NASH.
Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease.
The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.
研究概览
详细说明
Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases.
The cause of NASH is not completely understood and currently there is no effective treatment for this disease.
An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis.
Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management.
However, there has never been a randomized controlled trial evaluating the efficacy of weight reduction as a treatment for NASH.
Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve liver histology.
The objective of this project is to conduct a pilot study in preparation for a randomized controlled trial of weight reduction in the management of NASH.
In this study, 30 overweight or obese individuals with biopsy-proven NASH will be enrolled.
Twenty patients will be randomized to receive 48 weeks of intensive weight management using a combination of diet, exercise and behavior modification with a goal of 7-10% weight reduction.
This weight loss program is similar to programs used successfully in other overweight populations and to the intensive lifestyle program of the Diabetes Prevention Program and Look AHEAD.
The other 10 patients will be randomized to a control group where they will receive standard medical care and general counseling on healthy eating and exercise.
At the end of the 48-week study, patients will have a repeat liver biopsy that will be compared to their baseline biopsy.
The pilot study will establish the feasibility of recruiting and retaining, producing sustained weight loss and performing repeat liver biopsies in this population.
Based on the outcomes of this preliminary trial, this program will be further refined and readied for a larger-scale clinical trial.
研究类型
介入性
注册 (预期的)
30
阶段
- 阶段2
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
-
-
Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island Hospital
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Evidence of chronic steatohepatitis on liver biopsy.
- Elevated alanine or aspartate aminotransferase values (ALT > 41 or AST > 34) within 3 months of enrollment
- Absence of another form of liver disease
- Body mass index between 25-50 kg/m2.
- At least 18 years of age
- Absence of significant alcohol consumption (more than one standard drink per day).
- Able to walk 2 blocks or a quarter of a mile without stopping
- Willing to complete a two-week run-in period with successful completion of self-monitoring records.
Exclusion Criteria:
- < 18 years of age
- Significant alcohol consumption (> 1 standard drink per day)
- Contraindications to obtaining a liver biopsy
- Unable to walk 2 blocks or a quarter of a mile without stopping
- Currently pregnant or pregnant in the previous six months
- Currently engaged in an active weight-loss program or taking weight-loss medication
- Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol for 12 months, including illness likely to be terminal within 2 years, plans to move, substance abuse, or other significant psychiatric problems
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:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks
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Weight reduction at 48 weeks
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次要结果测量
结果测量 |
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Insulin sensitivity at 48 weeks
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Liver function test at 48 weeks
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Inflammatory markers and adipokine levels at 48 weeks
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Quality of life at 48 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。
调查人员
- 首席研究员:Kittichai Promrat, M.D.、Rhode Island Hospital/Brown University
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
- Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Bacon BR, Farahvash MJ, Janney CG, Neuschwander-Tetri BA. Nonalcoholic steatohepatitis: an expanded clinical entity. Gastroenterology. 1994 Oct;107(4):1103-9. doi: 10.1016/0016-5085(94)90235-6.
- Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8.
- Ueno T, Sugawara H, Sujaku K, Hashimoto O, Tsuji R, Tamaki S, Torimura T, Inuzuka S, Sata M, Tanikawa K. Therapeutic effects of restricted diet and exercise in obese patients with fatty liver. J Hepatol. 1997 Jul;27(1):103-7. doi: 10.1016/s0168-8278(97)80287-5.
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1月1日
研究完成 (实际的)
2007年12月1日
研究注册日期
首次提交
2005年12月14日
首先提交符合 QC 标准的
2005年12月14日
首次发布 (估计)
2005年12月15日
研究记录更新
最后更新发布 (估计)
2010年1月13日
上次提交的符合 QC 标准的更新
2010年1月12日
最后验证
2010年1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.