High Dose Insulin Therapy to Improve Liver Function in Patients With HCV Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Liver status improvments (biochemical and histological)
研究概览
简要总结
Insulin resistance is one of the key factors in defining a progressive course of chronic Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted insulin resistance as an adjuvant way to manage hepatitis C liver disease with promising results.
Long term therapy using high dose insulin was shown to significantly reduce insulin resistance in obese patients. In cardiac and critically ill patients, long term insulin was shown to produce better outcomes mainly by reducing the overt inflammatory response. Furthermore, initial results of ongoing trials are revealing more benefits of insulin therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients undergoing major liver resection was able to maximize their liver function post-operatively. This trial also demonstrated inhibition of the inflammatory response, improvement in liver glycogen, inhibition of apoptosis and stimulation of liver regeneration.
Putting in mind the potential ability of the liver to regenerate and regain better function. The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin resistance over time has led us to see the potential benefits of using insulin therapy on patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the pathophysiology of the disease at a cellular and a molecular level.
The investigators theorize that long-term high insulin therapy would be able to promote better liver function and slow down fibrosis and injury in this population of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Hepatitis C positive adult patients (serum HCV antibody positive)
- •MELD score 6-15 at the time of inclusion
- •Viral genotype "non-3"
- •Not on antiviral therapy
排除标准
- •HBV or HIV co-infection
- •Evidence of hepatocellular carcinoma at the start of the trial either by imaging and or AFP levels above 400
- •Undetectable HCV viral load (using HCV PCR test)
- •Recent infection or bleeding (in the last 3 months)
研究组 & 干预措施
Insulin/dextrose clamp
干预措施: Insulin (Drug)
结局指标
主要结局
Liver status improvments (biochemical and histological)
时间窗: 6 months
次要结局
- Insulin resistance(6 months)
- Inflammatory mediators(6 months)
研究者
peter metrakos
Director Multiorgan Transplant Program-MUHC
McGill University Health Centre/Research Institute of the McGill University Health Centre
