Red Blood Cell Lifespan Measurement in Diabetic Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Measurement of RBC survival in diabetic children using biotin-labeled RBCs
研究概览
简要总结
HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a marker of increasing importance both for assessing glycemic control in children with known diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor reliability in diagnosis and management of pediatric diabetes and the most plausible reason for this unreliability is that the reference ranges of HbA1c were established based on 120-day RBC lifespan observed in adults, without considering the RBC lifespan difference between children and adults. The proposed studies will for the first time determine RBC lifespan in diabetic children
详细描述
Screening visit: There will be one screening visit before the study. We will do some blood tests that will determine if the subjects can be in this study. If the subject is qualify, he/she will be asked to return for the following scheduled visits.
Study visit 1: We will draw a small amount of subject's blood from the IV. The study subject's blood will then be marked with biotin. We will give back the subject's blood marked with biotin through IV within 4 to 6 hours. Endotoxin analysis (conducted pre-infusion) and bacterial culture analysis (conducted post-infusion) will be performed. Twenty minutes after the blood transfusion, we will draw blood from the IV. After that, we will take out the IV and the subject can go home.
All follow-up study visits:
The subject will have a study visit 24 hours after receiving blood marked with biotin. After that, the subject will have a clinic visit every 7-10 days. These visits will end when we can no longer find the biotin marked blood cells in the subject's blood. This is expected to be approximately 12 weeks later.
At these visits, we will draw blood and also collect all blood glucose results in the past 7-10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with either type1 or type 2 diabetes between 4-18 years old
排除标准
- •consumption of biotin supplements or raw eggs within 30 days;
- •history of gastrointestinal blood loss;
- •heart failure ;
- •active viral or bacterial infection;
- •hemoglobinopathy;
- •prior history of liver disease with transaminases more than 3 times the upper limit of normal for age;
- •uncontrolled thyroid disease;
- •anemia (whole blood HCT<33);
- •history of renal disease (prior serum creatinine more than >1.5 mg/dlL);
- •detectable antibody to biotin.
研究组 & 干预措施
Biotin labeled RBCs in 4-10 year old diabetes children
Biotin labeled autologous RBCs will be transfused to the subjects
干预措施: biotin labeled RBCs (Drug)
Biotin labeled RBCs in 10-18 year old diabetes children
Biotin labeled autologous red blood cells will be transfused to the subjects
干预措施: biotin labeled RBCs (Drug)
结局指标
主要结局
Measurement of RBC survival in diabetic children using biotin-labeled RBCs
时间窗: 50 days to 120 days
the lifespan of red blood cells in children with diabetes
次要结局
未报告次要终点
研究者
Guohua An
Assistant Professor
University of Iowa