To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Odds of Type 1 Diabetes Mellitus child having a diabetic parent
研究概览
简要总结
Primary Objective:
To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics.
Secondary Objectives:
- To document the profile of Type 1 diabetes patients.
- To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated hemoglobin [HbA1c]) of Type 1 diabetes.
- To capture the current therapeutic management.
详细描述
The overall duration of this study is expected to be 12 months. The recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the patients shall be conducted after 15 days ± 5 days.
*Each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through centralized laboratories for all recruited patients.
Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Case
Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases
干预措施: Blood draw for insulin auto-anti body tests* (Drug)
Control
Age-matched non-diabetic controls as described in the inclusion criteria for controls
干预措施: Blood draw for insulin auto-anti body tests* (Drug)
结局指标
主要结局
Odds of Type 1 Diabetes Mellitus child having a diabetic parent
时间窗: 12 months
Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables
次要结局
- Characterization of this population by gender(12 months)
- Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients(12 months)
- Means of fasting blood glucose (FBG) in T1DM patients(12 months)
- Standard deviation of FBG in T1DM patients(12 months)
- Mean duration of diabetes in parent(12 months)
- Characterization of frequency of consultation(12 months)
- Characterization of diabetes education(12 months)
- Standard deviation of HbA1c in T1DM patients(12 months)
- Characterization of family history of diabetes(12 months)
- Characterization of this population by age(12 months)
- Characterization of this population by socio-economic profile(12 months)
- Distribution of prescribed therapies by type of insulin to T1DM patients(12 months)
- Duration of diabetes in parent(12 months)