Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Location contact
Frank Scheer, PhD
SUB_INVESTIGATOR
Jingyi Qian, PhD
CONTACT
Jingyi Qian, PhD
PRINCIPAL_INVESTIGATOR
Vy Nguyen, B.S.
CONTACT
Recruiting
NCT Number: NCT05838508
Effect of Physical Activity Pattern on Cardiometabolic Health
The goal of this study is to understand the interaction between the circadian system and physical activity.
Participants will:
* complete 2 inpatient stays * perform moderate exercise * be provided with identical meals * have frequent blood draws * provide urine and saliva samples
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The endogenous circadian system (i.e., an internal biological rhythm) plays an important role in regulating blood glucose, blood pressure, and energy expenditure. Physical activity improves health and reduces the risk for cardiovascular diseases and type 2 diabetes. The goal of this study is to understand the interaction between the circadian system and physical activity. We aim to test whether such relationship between the circadian system and physical activity can be used to enhance the health benefits of physical activity.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 18-45 yr old
- Body mass index (BMI) 18.5 - 34.9 kg/m2
- No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
- Willing to adhere to the protocol requirements for the duration of the study
Exclusion criteria
- Currently smoking/vaping or 5 or more years of smoking/vaping
- Currently pregnant or breastfeeding
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
- Any hospitalization due to COVID-19
- Inability to exercise for any reason
- Any known contraindication to exercise testing based on current ACSM guidelines
Treatment and study plan
Exercise Intervention
BehavioralResearch participants will be assigned to two exercise conditions.
Primary outcomes
-
glucose level
Time frame: 24-hour test period after exercise
mean glucose level after exercise session
-
mean arterial pressure
Time frame: 24-hour test period after exercise
mean arterial pressure after exercise session
Secondary outcomes
-
insulin sensitivity index
Time frame: about 12 and 24 hours after exercise
Oral Minimal Model method estimates mean insulin sensitivity based on blood glucose and insulin levels from two mixed meal tests after exercise session
-
beta-cell function index
Time frame: about 12 and 24 hours after exercise
Oral Minimal Model method estimates mean beta-cell function based on blood glucose, insulin and c-peptide levels from two mixed meal tests after exercise session
-
total peripheral resistance
Time frame: 24-hour test period after exercise
total peripheral resistance derived from BP waveform measured by finger plethysmography
-
autonomic nervous system activity
Time frame: 24-hour test period after exercise
derived by time-domain heart rate variability analysis
Other outcomes
-
resting energy expenditure
Time frame: 24-hour test period after exercise
energy expenditure will be measured at 1-2 hours interval by indirect calorimetry
-
respiratory exchange ratio
Time frame: 24-hour test period after exercise
respiratory exchange ratio will be measured at 1-2 hours interval by indirect calorimetry
Study contacts
Contact information is provided by the study sponsor or research team.
Jingyi Qian, PhD
CONTACT
Vy Nguyen, B.S.
CONTACT
Sponsors and collaborators
Lead sponsor
Brigham and Women's Hospital
Other
Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
Registry information
Acronym: PACE
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 1, 2023
- Registry last updated
- Jun 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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