The Impact Of Choline Administration On Oxidative Stress And Clinical Outcome Of Patients With Non-Alcoholic Fatty Liver Disease NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- effect on Oxidative stress marker as the mean change of Thiobarbituric acid reactive substances level
研究概览
简要总结
The study will be assessing the impact of choline supplementation in Non-alcoholic fatty liver disease patients using ultrasonography to show change in liver echogenicity, various laboratory tests as liver function, lipid profile and glucose control tests and finally on markers of oxidative stress as Thiobarbituric acid reactive substances and Leptin.
详细描述
Non-alcoholic fatty liver disease (NAFLD) has attracted increasing attention given its high prevalence, estimated at 20% to 44% in Western countries and 5% to 38% in Asia as well as its correlation with cardiovascular morbidity and mortality.
NAFLD is the result of hepatic fat accumulation in patients without a history of excessive alcohol consumption, predisposing medications or other defined liver disorders. NAFLD comprises a spectrum of liver disorders. At one end of this spectrum, is simple hepatic steatosis and the other end is non-alcoholic steatohepatitis (NASH) which is characterized by hepatocellular injury, inflammation and fibrosis sometimes leading to cirrhosis. It is considered the hepatic manifestation of metabolic syndrome, which is defined by the presence of central obesity, insulin resistance, hyperlipidemia, hyperglycemia, and hypertension.
According to the multiple parallel hits in NAFLD pathogenesis, the first hit is insulin resistance, which results in increased hepatic de novo lipogenesis and impaired adipose tissue lipolysis.These conditions cause an efflux of free fatty acids from the adipose tissue to the liver. The liver becomes vulnerable to a series of hits, including oxidative stress and dysregulation of adipokines such as leptin.
It has been also observed that fatty liver can occur both in people with a normal body mass index (BMI) (10-24% of the population has fatty liver) and in 95% of adults with obesity.
Choline is an essential nutrient for human health, which exerts various physiological functions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Patients from 18 to 65 years.
- •Gender: both males and females (age and sex matched in both groups).
- •Patients diagnosed with NAFLD via ultrasound (hepatic steatosis observation on ultrasound).
- •Treatment free from choline supplementation for the past 3 months prior starting the therapeutic regimen.
排除标准
- •Other liver diseases as viral hepatitis (B or C)
- •Alcohol consumption more than 40 g per week for the past 12 months, and life-time cumulative consumption more than 100 kg.
- •Autoimmune liver disease
- •Malignancy of any nature.
- •Any systemic failure (cardiovascular, renal or respiratory)
- •Patients with major psychiatric illness.
- •Pregnant or lactating women.
- •Diabetes mellitus .
结局指标
主要结局
effect on Oxidative stress marker as the mean change of Thiobarbituric acid reactive substances level
时间窗: 12 weeks
Measured as the mean change in Thiobarbituric acid reactive substances serum level (mmol/μg) at baseline and after 12 weeks of choline supplementation
次要结局
- effect on Inflammatory status as the mean change in leptin levels(12 weeks)
研究者
Amal A. Elkholy
Lecturer of Clinical Pharmacy
Ain Shams University