Effect of Physical Activity Pattern on Cardiometabolic Health

Not Applicable

Recruiting

• Conditions: Life Style
• Interventions: Behavioral: Exercise intervention

• Registration Number: NCT05838508
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Study Start: 2024-10-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 18-45 yr old
• Body mass index (BMI) 25-34.9 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise B-A Intervention	Exercise intervention	The Exercise B first, then the Exercise A intervention.
Exercise A-B Intervention	Exercise intervention	The Exercise A first, then the Exercise B intervention.

Primary Outcome Measures

Name	Time	Method
glucose level	24-hour test period after exercise	mean glucose level after exercise session
mean arterial pressure	24-hour test period after exercise	mean arterial pressure after exercise session

Secondary Outcome Measures

Name	Time	Method
total peripheral resistance	24-hour test period after exercise	total peripheral resistance derived from BP waveform measured by finger plethysmography
autonomic nervous system activity	24-hour test period after exercise	derived by time-domain heart rate variability analysis
insulin sensitivity index	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	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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States