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Clinical Trials/NCT05838508
NCT05838508RecruitingNot Applicable

Effect of Physical Activity Pattern on Cardiometabolic Health

Brigham and Women's Hospital2 sites in 1 country26 target enrollmentStarted: October 11, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
26
Locations
2
Primary Endpoint
glucose level

Study Overview

Brief 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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

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

  • total peripheral resistance(24-hour test period after exercise)
  • autonomic nervous system activity(24-hour test period after exercise)
  • insulin sensitivity index(about 12 and 24 hours after exercise)
  • beta-cell function index(about 12 and 24 hours after exercise)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jingyi Qian

Investigator

Brigham and Women's Hospital

Study Sites (2)

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