Trial Outcomes & Findings for Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics (NCT NCT02249793)

Results Overview

Aggregate communication as behavioral features has been collected using the cell phone data streams.

Recruitment status

COMPLETED

Target enrollment

6 participants

Primary outcome timeframe

3-4 months

Results posted on

2020-01-18

Participant Flow

Study Started 9/24/14, Ended 3/11/15 located at the Clinical and Translational Research Center, CTRC located at the University of Pennsylvania Hospital

Participant milestones

Participant milestones
Measure	Session 1, 48-hour Healthy volunteers; The observation time for the biosensor-derived data was a total of four months with two 48-hour sessions (Session 1 \& 2) scheduled two weeks apart to extend the biosensor platform by ambulatory blood pressure monitoring (ABPM) and timestamped dietary intake (SmartIntake) as well as by collection of timed biospecimens for multiomics analysis at 12-hour intervals.
Session 1, 48-hours Healthy Volunteers STARTED	6
Session 1, 48-hours Healthy Volunteers COMPLETED	6
Session 1, 48-hours Healthy Volunteers NOT COMPLETED	0
Session 2, 48-Hours Healthy Volunteers STARTED	6
Session 2, 48-Hours Healthy Volunteers COMPLETED	6
Session 2, 48-Hours Healthy Volunteers NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Male Healthy Volunteers n=6 Participants Males
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3-4 months

Aggregate communication as behavioral features has been collected using the cell phone data streams.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Calls and Text Messages Awake	18.7 Calls and text messages Interval 0.0 to 166.0
Calls and Text Messages Sleeping	0.9 Calls and text messages Interval 0.0 to 84.0

PRIMARY outcome

Timeframe: 48 hours

Ambulatory blood pressure monitoring

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure Difference Day versus Night	20.7 mmHg Standard Deviation 3.9
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure Awake	126.1 mmHg Standard Deviation 10.6
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure Asleep	106.8 mmHg Standard Deviation 11.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Percentage of Total Metabolites Plasma metabolome	5.4 percent
Percentage of Total Metabolites Saliva metabolome	5.6 percent

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Mobility Radius	6.8 miles Interval 0.0 to 193.4

PRIMARY outcome

Timeframe: 3-4 months

Number of phone calls placed and received

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Calls Sleeping	0.1 Calls Interval 0.0 to 10.0
Calls Awake	2.7 Calls Interval 0.0 to 48.0

PRIMARY outcome

Timeframe: 48 hours

Ambulatory blood pressure monitoring

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure Difference Day versus Night	20.7 mmHg Standard Deviation 3.3
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure Awake	78.5 mmHg Standard Deviation 9.1
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure Asleep	58.8 mmHg Standard Deviation 10.2

PRIMARY outcome

Timeframe: 3-4 months

The number of calls unanswered.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Unanswered Calls Awake	0.6 Unanswered calls Interval 0.0 to 9.0
Unanswered Calls Sleeping	0.03 Unanswered calls Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: 3-4 months

The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Unique Contacts Awake	7.2 Unique contacts Interval 0.0 to 71.0
Unique Contacts Sleeping	0.5 Unique contacts Interval 0.0 to 29.0

PRIMARY outcome

Timeframe: 3-4 months

The duration of calls (made + received)

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Call Duration Awake	820.4 Seconds Interval 0.0 to 16590.0
Call Duration Sleeping	22.0 Seconds Interval 0.0 to 3162.0

PRIMARY outcome

Timeframe: 3-4 months

The total length of all sms messages (sent + received) in characters

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Text Message Length Awake	868.0 n (characters) Interval 0.0 to 14840.0
Text Message Length Sleeping	47.0 n (characters) Interval 0.0 to 3089.0

PRIMARY outcome

Timeframe: 3-4 months

The number of sms messages (sent + received)

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Text Messages Awake	16.0 messages Interval 0.0 to 166.0
Text Messages Sleeping	0.8 messages Interval 0.0 to 75.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Self-reported Sleep Times [Survey]	7.6 hour Standard Deviation 2.9

SECONDARY outcome

Timeframe: 3-4 months

Hours asleep per each 24 hour period measured by actigraphy

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Time Asleep	7.931449224 hours Standard Deviation 0.7044404472

SECONDARY outcome

Timeframe: 3-4 months

Difference in locomotion between wake and sleep times

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Physical Activity Awake	1904.0 Counts/min Interval 0.0 to 55757.7
Physical Activity Sleeping	307.2 Counts/min Interval 0.0 to 29642.7

SECONDARY outcome

Timeframe: 48 hours

Nutrient intake will be measured using food photography

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Changes Over Time in Nutrient Intake - Energy Session 1	1967 Kcals Standard Deviation 488
Changes Over Time in Nutrient Intake - Energy Session 2	1609 Kcals Standard Deviation 601

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH Morning	23.3 relative expression Standard Deviation 13.5
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH Evening	17.9 relative expression Standard Deviation 9.4

SECONDARY outcome

Timeframe: 48 hours

Analysis was performed for all participants as a group.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome	3 genera

SECONDARY outcome

Timeframe: 48 hours

Analysis was performed for all participants as a group.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours	2 Proteins

SECONDARY outcome

Timeframe: 48 hours

Population: Kidney function was done to evaluate healthy volunteers during Session 1 and 2. Delta was calculated between Session 1 and 2 and averaged across subjects. Note that values for session1 was missing for two subjects, meaning that below reported mean and standard deviation reflect changes for four subjects.

Outcome measures

Outcome measures
Measure	Study Group n=6 Participants Healthy volunteers
Changes Over Time in Kidney Function	12.925 mg/dL Standard Deviation 115.468246

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Volunteers n=6 participants at risk Males
General disorders headache	16.7% 1/6 • Number of events 2 • 1 year All non serious AE were resolved, Serious AE: None

Additional Information

Dr. Carsten Skarke

Upenn

Phone: 215-573-0673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place