Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in the insulin resistance before and after hepatitis C clearance
研究概览
简要总结
Chronic hepatitis C infection has been linked to insulin resistance, which is the essential component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has been demonstrated to stimulate the secretion of several inflammatory factors known to play a role in the induction of insulin resistance. we investigated the changes in insulin resistance after hepatitis C clearance in the era of direct antivirals.
详细描述
the link between hepatitis C infection and insulin resistance has been established. Insuli resistance has been linked to poor response to interferon based therapy. recently, direct acting antiviral drugs are approved for hepatitis C elimination with high potency and safety. The aim of the study is to: 1. Determine the prevalence of insulin resistance among non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the utility of resistin as a potential biomarker IR among HCV infected 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis C treatment-naïve;
- •Non-diabetic patients.
排除标准
- •Seropositivity for hepatitis B virus infection;
- •Diabetes mellitus;
- •Bbody mass index ≥ 30 Kg/M*2;
- •History of alcohol consumption;
- •Endocrinopathies that may affect the glycemic homeostasis;
- •Other known causes of chronic liver disease; Hepatic decompensation [defined as history of gastrointestinal bleeding (melena and /or hematemesis), jaundice, coagulopathy, hepatic encephalopathy, and/or ascites]; bleeding diathesis;
- •Connective tissue diseases;
- •Autoimmune diseases;
- •Cardiac, respiratory or renal disease.
- •Patient receiving immuno-modulatory therapy or drugs that affect the blood glucose levels such as steroids or beta-blockers.
研究组 & 干预措施
Non-Diabetic Hepatitis C infected patients
- clinical examination,
- measurement of weight (Kg), height (meter), and waist circumference (cm).
- Calculation of the body mass index.
- Ultrasound abdominal examination.
- Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.
- Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).
- Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.
- measurement of serum levels of resistin before and at 12 weeks after treatment.
干预措施: Sofosbuvir 400 milligram (Drug)
Non-Diabetic Hepatitis C infected patients
- clinical examination,
- measurement of weight (Kg), height (meter), and waist circumference (cm).
- Calculation of the body mass index.
- Ultrasound abdominal examination.
- Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.
- Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).
- Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.
- measurement of serum levels of resistin before and at 12 weeks after treatment.
干预措施: Daclatasvir 60 milligram (Drug)
Non-Diabetic Hepatitis C infected patients
- clinical examination,
- measurement of weight (Kg), height (meter), and waist circumference (cm).
- Calculation of the body mass index.
- Ultrasound abdominal examination.
- Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.
- Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).
- Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.
- measurement of serum levels of resistin before and at 12 weeks after treatment.
干预措施: Ribavirin 400 milligram (Drug)
Non-Diabetic Hepatitis C infected patients
- clinical examination,
- measurement of weight (Kg), height (meter), and waist circumference (cm).
- Calculation of the body mass index.
- Ultrasound abdominal examination.
- Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included.
- Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin).
- Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment.
- measurement of serum levels of resistin before and at 12 weeks after treatment.
干预措施: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab (Drug)
结局指标
主要结局
Change in the insulin resistance before and after hepatitis C clearance
时间窗: at baseline and 12 weeks after sustained virologic response
Assess the change in the value of Homeostatic Model Assessment for Insulin resistance (Homeostatic Model Assessment for Insulin Resistance) after hepatitis C treatment by calculating the HOMA-IR for all patients at baseline and the re-calculation at 12 weeks after viral clearance to clarify the impact of hepatitis C treatment by direct antiviral drugs on insulin sensitivity.
次要结局
- Prevalence of insulin resistance among hepatitis C patients(at baseline)
- Sustained virologic response(at 12 weeks after treatment)
研究者
Sameh A. Lashen
Associate Professor of Internal Medicine.
Alexandria University