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Recruiting NCT05838508

Effect of Physical Activity Pattern on Cardiometabolic Health

No phase Interventional Life Style

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise intervention.
Who it may be relevant to
Registry conditions: Life Style. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • glucose level [Time frame: 24-hour test period after exercise]
  • mean arterial pressure [Time frame: 24-hour test period after exercise]
Secondary outcome measures (4)
  • insulin sensitivity index [Time frame: about 12 and 24 hours after exercise]
  • beta-cell function index [Time frame: about 12 and 24 hours after exercise]
  • total peripheral resistance [Time frame: 24-hour test period after exercise]
  • autonomic nervous system activity [Time frame: 24-hour test period after exercise]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT05838508 · 2023P001025 · R00HL148500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗