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

NCT ID: NCT06842225

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2029-06-30

Brief Summary

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.

Conditions

Metabolic Disorders; Physical Inactivity; Vascular Disease Risk

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

reduced physical activity

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Miami University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Ballard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Phillips Hall

Oxford, Ohio, United States

Countries

United States

Central Contacts

Kevin Ballard, PhD

Role: CONTACT

ballarkd@miamioh.edu

513-529-9247

Paul Reidy, PhD

Role: CONTACT

reidypt@miamioh.edu

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

02290-1R15HL177798-01

Identifier Type: -

Identifier Source: org_study_id