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
調査の概要
状態
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
入学 (実際)
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
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 |
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Study group
Healthy volunteers
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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
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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
時間枠:48 hours
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Ambulatory blood pressure monitoring
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48 hours
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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
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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
時間枠: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
時間枠:48 hours
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Ambulatory blood pressure monitoring
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48 hours
|
Unanswered Calls
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:3-4 months
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The number of sms messages (sent + received)
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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
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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
時間枠: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
時間枠: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
時間枠:48 hours
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Nutrient intake will be measured using food photography
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48 hours
|
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
時間枠:48 hours
|
48 hours
|
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Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
時間枠:48 hours
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Analysis was performed for all participants as a group.
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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
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
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 817759
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