Effect of Physical Activity Pattern on Cardiometabolic Health

Life Style Clinical Trial

Official title:

Effect of Physical Activity Pattern on Cardiometabolic Health

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
• 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
• 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

Related Conditions & MeSH terms

• Life Style

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