NCT00152815终止2 期
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
Johane Allard1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
研究概览
简要总结
The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD
- •Convincing evidence of negligible alcohol consumption (< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
- •If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study
- •Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine
排除标准
- •Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction)
- •Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis
- •Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy
- •Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry
- •Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry
- •Pregnant or lactating
研究组 & 干预措施
Vitamin E
Experimental
alpha-tocoperol, capsules, 2 per day
干预措施: antioxidant vitamin E (Drug)
Vitamin E
Experimental
alpha-tocoperol, capsules, 2 per day
干预措施: weight reduction and exercise (Behavioral)
结局指标
主要结局
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
时间窗: month 0 and month 12
次要结局
- Liver histology for steatosis and fibrosis staging(month 0 and month 12)
- Liver immuno-histochemistry for adducts of MDA: a product of LP(month 0 and month 12)
- Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation(month 0 and month 12)
- Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis(month 0 and month 12)
- Liver lipid peroxides and TNP-alpha(month 0, month 6 and month 12)
- Liver steatosis and volume will be assessed by ultrasound(month 0 and month 12)
- Liver enzymes and IR (HOMA and QUICKY) will also be measured(month 0, month 6 and month 12)
- Lipid peroxides, TNF-alpha, vitamin E and C in plasma(month 0, month 6 and month 12)
研究者
Johane Allard
Gastroenterologist, Professor of Medicine
University Health Network, Toronto
研究点 (1)
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