Effects of Alanine in Patients With Nonalcoholic Steatohepatitis
2012年10月9日 更新者:Keith D Lindor, M.D.
A Pilot Study: Therapeutic Effect of L-Alanine in Patients With Nonalcoholic Steatohepatitis
Purpose of this study is to assess the therapeutic efficacy of L-alanine in improving biological and histological findings by administrating 6-18g/day L-alanine for one year.
We will also assess the safety and toxicity profile of long-term administration of L-alanine.
研究概览
研究类型
介入性
注册 (实际的)
9
阶段
- 不适用
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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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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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 至 75年 (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:
- Males and females, age between 18 and 75
- Histological diagnosis of steatohepatitis with or without fibrosis made within one year of entry
- Transaminase levels (ALT or AST) more than 1.5 times the upper normal limit on at least two occasions with one assessment in three months or more prior to treatment of this study
- Previous and current alcohol consumption less than 20g per day by patient-provided information.
- Written informed consent specific for this protocol available prior to entry.
- Patients with diabetes and on stable medical management for six months prior to entry and an anticipated stable program throughout the study will be eligible. Medications that may be used include insulin, biguanides and sulfonylureas.
- Patients with congestive heart failure, hypertension and arrhythmia controlled by medications and without cardiac episodes during the past 6 months will be eligible.
Exclusion Criteria:
- Any causes for liver disease other than nonalcoholic steatohepatitis that are confirmed by patient history, laboratory data, or histological data
Decompensated liver disease based on laboratory data, or clinical manifestations
- Hemoglobin <11.0g/dl for male, <10.0 g/dl for female
- White blood cells <2000 /mm3
- Platelet count <50,000/mm3
- Prothrombin time >INR 1.5
- Total Bilirubin >2.0 g/dl
- Albumin <3.0/dl
- The presence of ascites
- The presence of bleeding varices
- The presence of spontaneous encephalopathy
- Any previous experimental treatment of NASH within the past 3 months such as betaine, thiazolidinediones, α-tocopherol, or UDCA
- Pre-existing diseases/situations that could interfere with the results or the completion of this trial.
Uncontrolled diabetes mellitus meeting following criteria in previous 3 months
- Fasting blood sugar >200 mg/dl
- Hemoglobin A1c >12%
- Renal or liver transplant patients
Renal dysfunction in previous 3 months
a) CCr <50ml/min
- Severe cardiovascular dysfunction in previous 6 months
- Congestive heart failure
- Uncontrolled hypertension
- Uncontrolled arrhythmia
- Patients with hyperlipidemia on a medical program for control of lipids which has had a change in drug treatment in the proceeding six months or with anticipated changes in the year of the study.
- Chronic pulmonary disease such as COPD requiring corticosteroid therapy in previous 3 months
- Active autoimmune or immunologically mediated diseases including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel diseases in previous 12 months
- Previous (in three years) or present malignant disease except for non-melanoma skin cancer
- Untreated hyperthyroidism and hypothyroidism
- Substance abuse of oral, I.V., or inhaled drugs.
- If patients with history of substance abuse are considered as participants in this trial, patients must have abstained from using the abused substance for at least one year.
- Patients receiving methadone within the past 6 months are also excluded.
- Any other conditions that would make the patients unsuitable for enrollment in the opinion of the investigator in terms of interference in completing the trial and/or results of trial.
- Pregnant women
- Unwillingness of patients and /or partner to use contraceptive during treatment and for 3 months after discontinuation of treatment.
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1个
单臂,主动治疗
|
6g of L-alanine (powder)once per day for the first month, twice per day for the second month, then three times per day from the third month for 10 months.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To assess the safety and tolerability of long-term L-alanine supplementation and the therapeutic efficacy of long-term L-alanine supplementation by evaluating liver biochemistry and histological findings.
大体时间:1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
---|---|
Determine the effect of L-alanine on gene profiles, anti-oxidant response and inflammatory response in hepatocytes. Evaluate possible correlation between therapeutic efficacy and gene profiles altered by L-alanine supplementation
大体时间:1 year
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1 year
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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
- Suzuki A, Charlton MR, Lymp JF, et al. A pilot study: No therapeutic effect of L-alanine in patients with nonalcoholic steatohepatitis. Food and Nutrition Sciences 2: 67-73, 2010.
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
2004年2月1日
初级完成 (实际的)
2006年6月1日
研究完成 (实际的)
2006年6月1日
研究注册日期
首次提交
2007年12月21日
首先提交符合 QC 标准的
2007年12月21日
首次发布 (估计)
2008年1月7日
研究记录更新
最后更新发布 (估计)
2012年10月11日
上次提交的符合 QC 标准的更新
2012年10月9日
最后验证
2012年10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.
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