NCT02614170已完成不适用
A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Measure C-peptide and Insulin in Healthy Individuals
研究概览
简要总结
The study objectives are described below:
- Obtain matched serum, plasma [(K2 EDTA, Sodium Heparin (NaH), Lithium Heparin (LiH)] and urine specimens collected from a minimum of 50 healthy subjects. Specimens will be used to determine a reference range for C-peptide and insulin assays, used as an aid in the assessment of C-peptide and insulin in adults.
- Obtain serum and urine specimens collected from a minimum of an additional 200 healthy subjects. Specimens will be used to determine a reference range for C-peptide and insulin assays, used as an aid in the assessment of C-peptide and insulin in adults.
- To store any remaining specimens for use in future assay development and to evaluate as yet undetermined assays for the development of IVDs, including additional C-peptide or insulin assays.
详细描述
The primary object of this study is to obtain a series of blood and urine specimens from women and men who are healthy with no history of abnormal blood sugar levels. The specimens will be used to evaluate new C-peptide and insulin assays (tests). Participants are being asked to voluntarily take part in this study because they are a healthy individual without a history of abnormal blood sugar levels.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, age ≥ 18 years
- •Fasting for 12 hours prior to blood draw and random urine collection
- •Able to understand and willing to provide informed consent
- •Normal HbA1c (e.g. less than 5.7%) and glucose (e.g. less than 100 mg/dL) levels
排除标准
- •Males and females, age <18 years
- •Has a current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, would deem the subject unhealthy and therefore, ineligible.
- •Has a history of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, is unstable at the time of enrollment.
- •Current diagnosis or prior history of any type of diabetes including gestational diabetes.
- •Currently taking or history of insulin therapy for any disease.
- •Elevated HbA1c level (e.g. greater than 5.7%)
- •Elevated glucose level (e.g. greater than or equal to 100 mg/dL)
- •Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.
- •History of seizures
- •Diagnosed with an infectious disease including any sexually transmitted diseases.
- •Diagnosed with HIV/AIDS or ever tested positive for HIV.
- •History of hepatitis
- •Subject that has had sexual contact with a person who has hepatitis within the last 12 months.
- •Pregnancy or lactation
- •Non-fasting for 12 hours prior to blood and random urine collection.
- •Hemolytic blood specimen
- •Unable to provide informed consent
结局指标
主要结局
Measure C-peptide and Insulin in Healthy Individuals
时间窗: 10 months
250 healthy subjects
次要结局
未报告次要终点
研究者
研究点 (1)
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