Metabolic DisordersNCT06842225
Interactive Roles of Cardiorespiratory Fitness and Adiposity on Glucose and Vascular Control After Physical Inactivity
A study testing reduced physical activity in people with Metabolic Disorders and Physical Inactivity, run by Miami University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorders, Physical Inactivity, Vascular Disease Risk
- What is being tested?
- reduced physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to 30 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Reidy, PhD contact
United States1 site, 1 recruiting
- Recruiting
Phillips Hall
Oxford, Ohio, 45056
Kevin Ballard, PhD, 513-529-9247, ballarkd@miamioh.edu
About this study
Official title: 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.
- Being tested
- reduced physical activity
- Keywords
- physical activity, glucose control, vascular function
- Medical subject headings
- Metabolic Diseases, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced physical activityOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Reduced physical activity | Experimental | 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. Receives: Other: reduced physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Daily Physical Activity
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.
Measured: 3 weeks
Oral Glucose Tolerance Test (OGTT)
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.
Measured: Days 0, 7, and 14
Continuous Glucose Monitoring
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).
Measured: 3 weeks
Femoral Artery Blood Flow
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.
Measured: Days 0, 7, and 14
Secondary outcomes (6)
Fat Mass and Fat-Free Mass
Fat mass (kg) and fat-free mass (kg) will be determined using bioelectrical impedance and dual x-ray absorptiometry.
Measured: Days 0, 7, and 14
Height
Height (cm) will be determined using a wall-mounted stadiometer.
Measured: Days 0
Central Arterial Stiffness
Carotid-femoral pulse wave velocity will be measured following 10 min of rest to assess central arterial stiffness.
Measured: Days 0, 7, and 14
Central Arterial Blood Pressure
Pulse wave analysis will be measured following 10 min of rest to assess central arterial blood pressure.
Measured: Days 0, 7, and 14
Blood Lipids
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).
Measured: Days 0, 7, and 14
Cardiorespiratory Fitness
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start8 Oct 2025
- Primary completion15 May 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Ballard, Miami University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842225
- Sponsor's protocol ID
- 02290-1R15HL177798-01
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.