Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Cell phones with internet access (so-called smartphones) represent a rich source for user activity data. Each time one places a call, sends a text message, or uses an app, a data trace is being produced which overall reflects the user's social activity and behavior. This data is called 'social sensing data'. Researchers connected this type of data to the health status of the person operating the cell phone. An example is that an outbreak of seasonal flu may lead to fewer calls and text messages among cell phone users. Thus, the social sensing data may show for example how severe an outbreak is and how fast it is spreading.
"Circadian rhythmicity" describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while rest and sleep occurs during nighttime. A disturbance of this pattern, for example by regular nightshift work, may lead to an increased disease risk, such as for the cardiovascular system, the heart and blood vessels. Natural factors within a body produce our 24-hour rhythm. This rhythm is affected by outside cues such as sunlight. Jet lag is a short-term form of a disturbed 24-hour rhythm. When a person travels fast through several time zones, by plane for example from the East to the West Coast of the US, s/he arrives with a time difference of 3 hours. Upon arrival, the body runs still at East Coast time, but is exposed to the environmental cues following the West Coast time, which may make the person feel groggy and disoriented at first. Within a couple of days the body time usually adjusts and the complaints discontinue.
The current study wishes to look for a relationship between patterns in the participant's cell phone use (Android only at this point) and several of the bodily functions. As bodily functions the investigators will measure blood pressure and breakdown products (metabolites) in urine, blood and saliva samples. The investigators will collect stool samples and use swabs to collect the microbes inhabiting the mouth as well as the rectum. The investigators will also measure messenger ribonucleic acid (mRNA), messenger products of the participant's heritable information, in the blood. A cell phone application called "Ginger.io" will collect the participants' cell phone usage information. This application will also ask the participant several questions during the installation, during participation as well as at the end. Furthermore, the investigators will ask the participant about the dietary intake and habits.
The aim is to learn how the 24-hour rhythm is connected to the social activity and behavior as well as blood pressure and metabolites as markers for the health status.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
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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
Descripción
Inclusion Criteria:
- Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI;
- Volunteers are capable of giving informed consent;
- 25-35 years of age;
- Own a cell phone with internet access (smartphone with Android operating system only at this point) which installs the social sensing application ginger.io;
- Non-smoking;
- Male subjects only if feasible during recruitment; and
- In case female volunteers are invited to enroll: non-pregnant, female subjects must consent to a urine pregnancy test.
Exclusion Criteria:
- Recent travel across time zones (within the past month);
- Planned travel across time zones during the planned study activities;
- Volunteers with irregular work hours, e.g. night shifts.
- Use of illicit drugs;
- Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Study group
Healthy volunteers
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Calls and Text Messages
Periodo de tiempo: 3-4 months
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Aggregate communication as behavioral features has been collected using the cell phone data streams.
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3-4 months
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Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure
Periodo de tiempo: 48 hours
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Ambulatory blood pressure monitoring
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48 hours
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Percentage of Total Metabolites
Periodo de tiempo: 48 hours
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Percentage of metabolites displaying different abundances in biosamples collected during the morning hours versus evening hours.
Analysis was performed for all participants as a group.
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48 hours
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Mobility Radius
Periodo de tiempo: 3-4 months
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The approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)
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3-4 months
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Calls
Periodo de tiempo: 3-4 months
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Number of phone calls placed and received
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3-4 months
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Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
Periodo de tiempo: 48 hours
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Ambulatory blood pressure monitoring
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48 hours
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Unanswered Calls
Periodo de tiempo: 3-4 months
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The number of calls unanswered.
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3-4 months
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Unique Contacts
Periodo de tiempo: 3-4 months
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The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity
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3-4 months
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Call Duration
Periodo de tiempo: 3-4 months
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The duration of calls (made + received)
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3-4 months
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Text Message Length
Periodo de tiempo: 3-4 months
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The total length of all sms messages (sent + received) in characters
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3-4 months
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Text Messages
Periodo de tiempo: 3-4 months
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The number of sms messages (sent + received)
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3-4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-reported Sleep Times [Survey]
Periodo de tiempo: 3-4 months
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Cell phone administered survey where participants indicated start and end of sleep times.
From this the total hours of sleep per night was calculated.
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3-4 months
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Time Asleep
Periodo de tiempo: 3-4 months
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Hours asleep per each 24 hour period measured by actigraphy
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3-4 months
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Physical Activity
Periodo de tiempo: 3-4 months
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Difference in locomotion between wake and sleep times
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3-4 months
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Changes Over Time in Nutrient Intake - Energy
Periodo de tiempo: 48 hours
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Nutrient intake will be measured using food photography
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48 hours
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Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
Periodo de tiempo: 48 hours
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48 hours
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Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
Periodo de tiempo: 48 hours
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Analysis was performed for all participants as a group.
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48 hours
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Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
Periodo de tiempo: 48 hours
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Analysis was performed for all participants as a group.
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48 hours
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Changes Over Time in Kidney Function
Periodo de tiempo: 48 hours
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48 hours
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carsten Skarke, MD, University of Pennsylvania
- Investigador principal: Garret A FitzGerald, MD, University of Pennsylvania
- Investigador principal: Aalim Weljie, PhD, University of Pennsylvania
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 817759
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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