Evaluation of Continuous Blood Glucose Monitoring Method for Detection of Alterations in Glucose Homeostasis in Beta Thalassemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- number of thalassemic patients with impaired glucose tolerance
研究概览
简要总结
The aim of the study is to:
- Assess the pattern of glucose homeostasis in patients with B thalassemia .
- To detect early impairment in glucose metabolism and prediabetic state in B thalassemia patients using continuous glucose monitoring system.
- To study the prevalence and type of DM in B thalassemia patients.
- A comparative study of standard insulin therapy compared to insulin pump therapy in thalassemic diabetic patients will be done.
The study will include screening of 200 children and adolescents who are regularly attending the Hematology Oncology Clinic and fulfilling the inclusion criteria for abnormalities of glucose homeostasis.
A pilot study will be done on 15 patients with abnormal glucose tolerance which will include:
A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration .
B-Therapeutic intervention:
Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to
• Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy.
详细描述
β-thalassemia is a worldwide distributed monogenic red cell disorder, characterized by the absence or reduced β-globin chain synthesis (De Franceschi et al.,2013).
Approximately 7% of the global population is carrier of such disorders, and 300,000-400,000 babies with severe forms of these diseases are born each year (Weatherall, 2005; Modell et al., 2008). Severe hereditary hemoglobin disorders of red cells occur at highest frequency in tropical regions.
Hemoglobinopathies constitute the single most common monogenic defect worldwide, and among hemoglobin disorders, the thalassemias prominently contribute to (Weatherall et al., 2001; de Franceschi et al., 2011). β-thalassemias (β-thal) are characterized by the presence of mutations on beta-globin gene resulting in the absence or reduced synthesis of β-globin chains.
Glucose metabolism disturbances, among other endocrinopathies, are a common feature of β -thalassaemia . Pancreatic iron overload and diabetes mellitus (DM) are common in thalassemia major patients. However, the relationship between iron stores and glucose disturbances is not well defined (Leila et al., 2012).
The etiology of DM in β -thalassemia is suggested to be due to the effect of iron overload on the different tissues controlling the carbohydrate homeostatic mechanisms; including the pancreas and liver. However, controversy about the etiology of this glycemic abnormality still exists (Weinberg 2007).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B-thalassemia as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography ( HPLC) & reticulocytic count ( Wethers, 2000; Fung et al., 2008).
- •Patients with B-thalassemia aged less than 20 years.
- •Patients with B-thalassemia on regular blood transfusion.
- •Patients with B-thalassemia iron chelation therapy.
- •Patients with s. ferritin >1000(Soliman AT, et al.; 2013
排除标准
- •Alpha thalassemia and sickle thalassemia patients.
- •Patients with other endocrine abnormalities.
- •Patients with family history of DM or other systemic illness.
- •Patients with other hereditary diseases.
研究组 & 干预措施
daibetic thalassemic patients on SC insulin
A pilot study will be done on 20 patients with abnormal glucose tolerance which will include:
A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et al., 2009).
B-Therapeutic intervention:
Thalassemia patients who proved to have diabetes according to the ADA criteria will be put on sc insulin
干预措施: insulin pump/CGMS (Device)
daibetic thalassemic patients on insulin pump
A pilot study will be done on 20 patients with abnormal glucose tolerance which will include:
A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et
B-Therapeutic intervention:
Thalassemia patients who proved to have diabetes according to the ADA criteria will be put on insulin pump
干预措施: insulin pump/CGMS (Device)
结局指标
主要结局
number of thalassemic patients with impaired glucose tolerance
时间窗: 2 years
to find out the number of patients with thalassemia major having impaired glucose tolerance
次要结局
- number of thalassemic patients with diabetes mellitus(2 years)
- control of diabetic thalassemic patients on insulin pump(2 years)
研究者
Amira Abd el moneam
Professor of pediatrics
Ain Shams University
