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

2020年1月5日 更新者: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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

6

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

25年~35年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Healthy volunteers

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:コホート
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
Study group
Healthy volunteers

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Calls and Text Messages
時間枠: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
時間枠:48 hours
Ambulatory blood pressure monitoring
48 hours
Percentage of Total Metabolites
時間枠: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
時間枠: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
時間枠:3-4 months
Number of phone calls placed and received
3-4 months
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
時間枠:48 hours
Ambulatory blood pressure monitoring
48 hours
Unanswered Calls
時間枠:3-4 months
The number of calls unanswered.
3-4 months
Unique Contacts
時間枠: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
時間枠:3-4 months
The duration of calls (made + received)
3-4 months
Text Message Length
時間枠:3-4 months
The total length of all sms messages (sent + received) in characters
3-4 months
Text Messages
時間枠:3-4 months
The number of sms messages (sent + received)
3-4 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Self-reported Sleep Times [Survey]
時間枠: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
時間枠:3-4 months
Hours asleep per each 24 hour period measured by actigraphy
3-4 months
Physical Activity
時間枠:3-4 months
Difference in locomotion between wake and sleep times
3-4 months
Changes Over Time in Nutrient Intake - Energy
時間枠:48 hours
Nutrient intake will be measured using food photography
48 hours
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
時間枠:48 hours
48 hours
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
時間枠:48 hours
Analysis was performed for all participants as a group.
48 hours
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
時間枠:48 hours
Analysis was performed for all participants as a group.
48 hours
Changes Over Time in Kidney Function
時間枠:48 hours
48 hours

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Carsten Skarke, MD、University of Pennsylvania
  • 主任研究者:Garret A FitzGerald, MD、University of Pennsylvania
  • 主任研究者:Aalim Weljie, PhD、University of Pennsylvania

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年9月1日

一次修了 (実際)

2017年12月1日

研究の完了 (実際)

2017年12月1日

試験登録日

最初に提出

2014年3月25日

QC基準を満たした最初の提出物

2014年9月25日

最初の投稿 (見積もり)

2014年9月26日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月18日

QC基準を満たした最後の更新が送信されました

2020年1月5日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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