Recruiting

Observational Study

Sponsor:

Miami University

Code:

NCT06842225

Conditions

Metabolic Disorders

Physical Inactivity

Vascular Disease Risk

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

reduced physical activity

Study Details

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 ID

NCT06842225

Start date

Oct 8, 2025

Status verified date

Oct, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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).

Primary outcome measure

  • Changes in Daily Physical Activity [ Time Frame: 3 weeks ]
  • Oral Glucose Tolerance Test (OGTT) [ Time Frame: Days 0, 7, and 14 ]
  • Continuous Glucose Monitoring [ Time Frame: 3 weeks ]
  • Femoral Artery Blood Flow [ Time Frame: Days 0, 7, and 14 ]

Central Contacts and Locations

Central contacts

Locations

Phillips Hall

Recruiting

Oxford, Ohio, United States, 45056

Contacts

More Information

Sponsor

Miami University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • physical activity
  • glucose control
  • vascular function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Miami University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.