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临床试验/NCT07238530
NCT07238530已完成不适用

Evaluation of Insulin Resistance in Hepatitis C Infected Thalassemia Children and Survivors of Childhood Malignancy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
The primary outcome measure was to study the occurrence of insulin resistance in hepatitis C virus infected children who were either thalassemic or survivors of childhood malignancy

研究概览

简要总结

The goal of this observational study was to study the occurrence of insulin resistance in hepatitis C virus infected children who were either thalassemic or survivors of childhood malignancy and its correlation to the HCV viral load and other metabolic factors.

The main question it aims to answer is:

  1. Do children infected with Hepatitis C have a higher incidence of Insulin resistance compared to healthy controls of same age and gender?
  2. Is Insulin resistance occurence affected by HCV viral load, blood transfusion frequency, or metabolic factors? Researchers will compare hepatitis c infected children who are either thalassemic or survivors of childhood malignant to healthy age and sex matched controls.

Participants will be subjected to:

  • standardized Questionnaires,
  • physical examination and
  • laboratory investigations including liver functions (ALT, AST, Alkaline phosphatase), Prothrombin time, serum ferritin level, albumin, fasting glucose, fasting insulin level and Insulin resistance assessment by HOMA IR calculation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • hepatitis C virus ribonucleic acid (RNA) positive children, who were following up at the pediatric hematology and oncology clinic

排除标准

  • patients with concurrent active hepatitis B virus infection (positive for hepatitis B surface antigen) or
  • autoimmune hepatitis,
  • primary biliary cirrhosis (PBC),
  • sclerosing cholangitis,
  • haemochromatosis,
  • α1-antitrypsin deficiency,
  • Wilson's disease,
  • patients with obesity (BMI > 25), or
  • Type 2 DM.

结局指标

主要结局

The primary outcome measure was to study the occurrence of insulin resistance in hepatitis C virus infected children who were either thalassemic or survivors of childhood malignancy

时间窗: over a period of 6 months

Insulin resistance was assessed by using Homeostasis Model Assessment (HOMA) index

次要结局

  • Secondary outcome measure was to assess correlation between insulin resistance and HCV viral load and metabolic parameters.(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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