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临床试验/NCT03141398
NCT03141398撤回不适用

Continuous Glucose Monitoring (CGM) Versus Oral Glucose Tolerance Test (OGTT) Versus T2* MRI Of The Pancreas In High-Risk Group (Hemoglobinopathies, Lymphoma & Acute Lymphoblastic Leukemia): A Comparative Study

Hamad Medical Corporation0 个研究点开始时间: 2017年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas

研究概览

简要总结

A prospective, observational, comparative study with no intervention.The objective of the study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C (Glycated Hemoglobin) and their relation to iron overload detected by T2* MRI of the pancreas in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance and to study the different factors that may affect the glycemic control in these patients in relation to their results like the Dose of corticosteroids and chemotherapy in ALL and Hemoglobinopathies, Liver function in ALL and Hemoglobinopathies, and Serum ferritin in Hemoglobinopathies and their transfusion status. Using Validated Tools with Permission, the participants will be selected through probability (random) sampling method with expected subjects numbers ALL/L: 30-50, Thalassemia Major: 20, Sickle cell disease: 20.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • This study will include participants who are High-risk patients to develop glycemic abnormalities:
  • Thalassemia major and SCD (beta cell toxicity and hepatic siderosis)
  • ALL/L ( beta cell injury and hepatic injury due to chemotherapy, and insulin resistance due to corticosteroids)

排除标准

  • Age < 14 years;
  • Other systemic diseases, renal disorders or malnourished;
  • Patients and unwilling to participate in the study.

结局指标

主要结局

Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas

时间窗: 12 Months

Compare the efficiency of detecting glycemic abnormalities using CGMS versus OGTT vs HbA1C. in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance. Detect the prevalence of glycemic abnormalities detected in the same group of patients (high-risk patients) using three different modalities of testing (CGMS, OGTT, HbA1C)and T2\*MRI for pancreas

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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