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Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics

5 janvier 2020 mis à jour par: Carsten Skarke, MD, University of Pennsylvania

Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics

As citizens of the information age, humans leave digital traces of behavior in their communication and movement patterns through our cell phone. The Global Positioning System (GPS) technology tracks the way persons commute to school or work or when visiting family and friends. 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 humans rest and sleep during nighttime. The current study wishes to look for a relationship between patterns in participants' cell phone use (Android only at this point) and several of their bodily functions.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

6

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 35 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Healthy volunteers

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Study group
Healthy volunteers

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Calls and Text Messages
Délai: 3-4 months
Aggregate communication as behavioral features has been collected using the cell phone data streams.
3-4 months
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure
Délai: 48 hours
Ambulatory blood pressure monitoring
48 hours
Percentage of Total Metabolites
Délai: 48 hours
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.
48 hours
Mobility Radius
Délai: 3-4 months
The approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)
3-4 months
Calls
Délai: 3-4 months
Number of phone calls placed and received
3-4 months
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
Délai: 48 hours
Ambulatory blood pressure monitoring
48 hours
Unanswered Calls
Délai: 3-4 months
The number of calls unanswered.
3-4 months
Unique Contacts
Délai: 3-4 months
The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity
3-4 months
Call Duration
Délai: 3-4 months
The duration of calls (made + received)
3-4 months
Text Message Length
Délai: 3-4 months
The total length of all sms messages (sent + received) in characters
3-4 months
Text Messages
Délai: 3-4 months
The number of sms messages (sent + received)
3-4 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Self-reported Sleep Times [Survey]
Délai: 3-4 months
Cell phone administered survey where participants indicated start and end of sleep times. From this the total hours of sleep per night was calculated.
3-4 months
Time Asleep
Délai: 3-4 months
Hours asleep per each 24 hour period measured by actigraphy
3-4 months
Physical Activity
Délai: 3-4 months
Difference in locomotion between wake and sleep times
3-4 months
Changes Over Time in Nutrient Intake - Energy
Délai: 48 hours
Nutrient intake will be measured using food photography
48 hours
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
Délai: 48 hours
48 hours
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
Délai: 48 hours
Analysis was performed for all participants as a group.
48 hours
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
Délai: 48 hours
Analysis was performed for all participants as a group.
48 hours
Changes Over Time in Kidney Function
Délai: 48 hours
48 hours

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Carsten Skarke, MD, University of Pennsylvania
  • Chercheur principal: Garret A FitzGerald, MD, University of Pennsylvania
  • Chercheur principal: Aalim Weljie, PhD, University of Pennsylvania

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2014

Achèvement primaire (Réel)

1 décembre 2017

Achèvement de l'étude (Réel)

1 décembre 2017

Dates d'inscription aux études

Première soumission

25 mars 2014

Première soumission répondant aux critères de contrôle qualité

25 septembre 2014

Première publication (Estimation)

26 septembre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 janvier 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 janvier 2020

Dernière vérification

1 janvier 2020

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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