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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05838508
Other study ID # 2023P001025
Secondary ID K99HL148500
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2024
Est. completion date August 30, 2026

Study information

Verified date May 2024
Source Brigham and Women's Hospital
Contact Jingyi Qian, PhD
Phone 6175257423
Email jqian@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 26
Est. completion date August 30, 2026
Est. primary completion date August 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - 20-45 yr old - Body mass index (BMI) 20-34.9 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise intervention
Research participants will be assigned to two exercise conditions.

Locations

Country Name City State
United States Jingyi Qian Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other resting energy expenditure energy expenditure will be measured at 1-2 hours interval by indirect calorimetry 24-hour test period after exercise
Other respiratory exchange ratio respiratory exchange ratio will be measured at 1-2 hours interval by indirect calorimetry 24-hour test period after exercise
Primary glucose level mean glucose level after exercise session 24-hour test period after exercise
Primary mean arterial pressure mean arterial pressure after exercise session 24-hour test period after exercise
Secondary insulin sensitivity index Oral Minimal Model method estimates mean insulin sensitivity based on blood glucose and insulin levels from two mixed meal tests after exercise session about 12 and 24 hours after exercise
Secondary beta-cell function index 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 about 12 and 24 hours after exercise
Secondary total peripheral resistance total peripheral resistance derived from BP waveform measured by finger plethysmography 24-hour test period after exercise
Secondary autonomic nervous system activity derived by time-domain heart rate variability analysis 24-hour test period after exercise
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