Interactive Roles of Cardiorespiratory Fitness and Adiposity on Glucose and Vascular Control After Physical Inactivity

February 18, 2025 updated by: Kevin Ballard, Miami University

Interactive Roles of Cardiorespiratory Fitness and Adiposity on Recovery of Impaired Glucose and Vascular Control After Physical Inactivity

The far-reaching negative health effects of the reduced physical activity (RPA) epidemic are often overlooked by the general population and health professionals. Short-term RPA induces cardiometabolic dysfunction, including impaired glucose control and vascular function, that may precede disease development. The impact of existing health status on RPA-induced cardiometabolic dysfunction and recovery of impaired glucose control following RPA is unexplored. Thus, the investigators' objectives are 1) to investigate the effect of existing health status (cardiorespiratory fitness and adiposity) on the recovery of impaired glucose control following a period of RPA and 2) to determine the role of vascular function as a mechanism of impaired glucose control. The investigators' final objective is to 3) expose undergraduate students to meritorious biomedical clinical research methods. The investigators have piloted the clinical research methods and analysis with undergraduate researcher associates and are well-prepared to complete this proposal. Preliminary data show that low cardiorespiratory fitness and/or high adiposity impair the recovery of glucose control following short-term RPA. Thus, the investigators aim to examine the interactive role of health status (cardiorespiratory fitness and adiposity) on the ability to recover impaired glucose control following short-term RPA. The investigators also seek to examine changes in vascular function as a mechanism of recovery of impaired glucose control following a return to normal PA. The investigators will recruit men and women with divergent health status (cardiorespiratory fitness and adiposity) to examine glucose control and vascular function during 7-d of normal PA, 7-d of RPA, and 7-d of resumption of normal RA. Continuous glucose monitoring and oral glucose tolerance tests will be performed to assess glucose control. Increases in vascular shear stress induced by passive leg movement and central arterial stiffness will be measured to assess vascular function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Oxford, Ohio, United States, 45056
        • Phillips Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males and females 18 to 40 years of age.
  • Ability to safely ride an electric scooter (e-scooter) for at least 10 minutes.
  • Active (>7000 steps per day, walking > 1 mile a day outside)
  • Stable body weight for at least 1 year
  • aerobic fitness level, CRF is < 9 and >14 METS
  • Visceral adipose tissue <130 cm2 or ≥130 cm2 for men and <100 cm2 or ≥100 cm for women

Exclusion Criteria:

  • Any injury preventing them from exercising regularly at the time of the screening.
  • Implantable defibrillator or pacemaker
  • Active cancer
  • Alcohol or drug abuse
  • Use of an assistive walking device
  • Presence of significant signs/symptoms of cardiovascular, metabolic, or pulmonary disease (determined from the American College of Sports Medicine (ACSM) Health History Questionnaire)
  • Daily vitamin consumption of > 500mg per day during the study
  • Acetaminophen or aspirin use during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Reduced physical activity
We will recruit, screen, and enroll eligible participants (18-40y) across the following four groups: high CRF/low adiposity, high CRF/high adiposity; low CRF/low adiposity; low CRF/high adiposity. Each participant will undergo a three-week study. For the first week, participants will be instructed to maintain their normal level of physical activity. For the second week, participants' schedules will be examined, and strategies designed to reduce steps (by at least 2000 steps) and physical activity. To assist in reducing walking and increased sitting, participants will be given seated electric scooters to use whenever they normally walk. The scooters will be returned on the third week, and participants will be instructed to resume their normal physical activity. During the entire three weeks, participants will wear a continuous glucose monitor and a physical activity monitor.
Other: reduced physical activity
Each participant will undergo a three-week study. For the first week (day -7 to day 0), participants will be instructed to maintain their normal level of physical activity. For the second week (day 0 to day 7), the reduced physical activity (RPA) week, participants' schedules will be examined, and strategies designed to reduce steps (by at least 2000 steps) and physical activity (by taking elevators and short-cuts, etc.) by increasing sitting time >10%. To assist in reducing walking and increased sitting, participants will be given seated electric scooters to use whenever they normally walk. The scooters will be returned on the third week (day 7 to day 14), and participants will be instructed to resume their normal physical activity. During the entire three weeks, participants will wear a continuous glucose monitor (CGM) and a physical activity monitor (ActivPal).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Daily Physical Activity
Time Frame: 3 weeks
Accelerometers will be use to measure changes in daily physical activity during the three week study duration. Accelerometer data to be reported includes: daily number of steps, daily sitting time, daily stepping time, total sedentary time, and activity score.
3 weeks
Oral Glucose Tolerance Test (OGTT)
Time Frame: Days 0, 7, and 14
On the morning of each OGTT, participants will arrive in the lab following an 8-10 h fast. An indwelling intravenous catheter will be placed into a forearm vein. Baseline (0 min) blood samples will be collected into heparinized evacuated tubes following 15 min of seated rest. Participants will consume a volume of glucose tolerance beverage containing 1 gram of glucose/kg of lean body mass to control for expected differences in body and fat mass between individuals. Participants will remain rested in the reclined position for the duration of the OGTT. Blood samples will be collected at 30, 60, 90, and 120 min post drink. Heparinized blood samples will be utilized to assess blood glucose using the Contour Next blood glucose monitoring system.
Days 0, 7, and 14
Continuous Glucose Monitoring
Time Frame: 3 weeks
Participants will wear CGM sensors for the duration of the study, with the first sensor being placed on day -7 and a second sensor replacing it on day 0. Data will be exported and quality-checked data will be imported into the IGlu Application in R Studio and analyzed using the following parameters: Night hours set from 10 PM to 7 AM; Time above (high) set to 140 mg/dL; Time above (low) set to 120 mg/dL; Time in range set to 70-120 mg/dL; Time below (high) set to 70 mg/dL; Time below (low) set to 54 mg/dL; Data reported using this software includes weekly and daily means, standard deviations (SD), coefficient of variations (CV), medians, time below range < 54 mg/dL (TBR <54), time below range < 70 mg/dL (TBR <70), time in range 70-120 mg/dL (TIR 70-120), time above range >120 mg/dL (TAR >120), time above range >140 mg/dL (TAR >140), mean amplitude of glycemic excursions (MAGE), and area under the curve (AUC).
3 weeks
Femoral Artery Blood Flow
Time Frame: Days 0, 7, and 14
Passive leg movement (PLM)-induced reactive hyperemia will be measured to assess peripheral vascular function. Briefly, the PLM technique involves passive movement of the leg to elicit a reactive hyperemic response measured by high-frequency ultrasonographic imaging. Diameter and blood velocity in the common femoral artery will be measured following 15 minutes of seated rest using a 5 to 12MHz multi-frequency linear array transducer connected to a high-resolution ultrasound. Arterial diameter and velocity will be recorded continuously for 60 seconds at baseline and 60 seconds during PLM. Femoral artery blood flow and shear rate (estimate of shear stress) will be calculated from arterial diameter and blood velocity measurements.
Days 0, 7, and 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fat Mass and Fat-Free Mass
Time Frame: Days 0, 7, and 14
Fat mass (kg) and fat-free mass (kg) will be determined using bioelectrical impedance and dual x-ray absorptiometry.
Days 0, 7, and 14
Height
Time Frame: Days 0
Height (cm) will be determined using a wall-mounted stadiometer.
Days 0
Central Arterial Stiffness
Time Frame: Days 0, 7, and 14
Carotid-femoral pulse wave velocity will be measured following 10 min of rest to assess central arterial stiffness.
Days 0, 7, and 14
Central Arterial Blood Pressure
Time Frame: Days 0, 7, and 14
Pulse wave analysis will be measured following 10 min of rest to assess central arterial blood pressure.
Days 0, 7, and 14
Blood Lipids
Time Frame: Days 0, 7, and 14
A blood sample will be collected during fasted conditions on Days 0, 7, and 14 for determination of blood lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides).
Days 0, 7, and 14
Cardiorespiratory Fitness
Time Frame: Day 0
On the screening day, participants will perform a Balke-graded exercise treadmill test to assess cardiorespiratory fitness. This test will be conducted on a treadmill and lasts between about 10 and 20 minutes. Heart rate, oxygen consumption, and rating of perceived exertion (RPE) will be monitored every minute during the test.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Miami University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02290-1R15HL177798-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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