- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02614170
A Prospective Collection of Peripheral Blood and Urine Specimens to Study C-peptide and Insulin in Healthy Individuals
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.
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Gulf Shores, Alabama, Estados Unidos, 36542
- Fundamental Research LLC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
A minimum of 250 subjects will be enrolled in this study. Healthy women and men greater than or equal to 18 years of age having donated a single blood draw, a random urine specimen, and a 24-hour urine collection specimen will be eligible.
Each site will evaluate and select patients for enrollment using the inclusion and exclusion criteria listed below. Study subjects should be selected from all available patients at the site. Each patient may be entered into the study only once.
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Measure C-peptide and Insulin in Healthy Individuals
Periodo de tiempo: 10 months
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250 healthy subjects
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10 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Diana Dickson, Fujirebio Diagnostics, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- FDI-115
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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