Metabolic DiseasesNCT06301243
Molecular Signature of Inactivity Induced Exercise Responsiveness
A study testing Inactivity in people with Metabolic Diseases and Aerobic Exercise, run by Concordia University Wisconsin at 1 site in United States.
Trial summary
Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases, Aerobic Exercise
- What is being tested?
- Inactivity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- free from acute or chronic illness (cardiac, pulmonary, liver, or kidney abnormalities, cancer, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other known metabolic disorders)
- free from orthopedic limitations (including any artificial joints) no known lidocaine allergy
- do not currently smoke or participate in other forms of tobacco use.
- not currently in a structured exercise program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases.
- Conditions
- Metabolic Diseases, Aerobic Exercise
- Being tested
- Inactivity
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InactivityOther
Also called Sedentary
Low physical activity level prior to the exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Inactive | Experimental | Subjects will be asked to be sedentary prior to an acute exercise bout (<5,000 steps as measured by a physical activity monitor). Receives: Other: Inactivity |
| Normal activity | Placebo comparator | Subjects will be asked to have normal activity prior to an acute exercise bout (>8,500 steps as measured by a physical activity monitor). Receives: Other: Inactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating lipid and carbohydrate metabolism
Investigate the role of sex and inactivity on lipid and carbohydrate metabolism following a bout of aerobic exercise.
Measured: Baseline; 20 and 40, and 60 minutes into exercise; and every 30 minutes after exercise up to 4 hours
Basal and post-exercise gene expression with inactivity
Study the role of inactivity on basal and exercise-induced gene expression in skeletal muscle.
Measured: Baseline; 4 hours after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Gries, Concordia University Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301243
- Sponsor's protocol ID
- FY24-62
- Status last verified
- Feb 2026
- First submitted
- 29 Feb 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Signature of Inactivity Induced Exercise Responsiveness
- ClinicalTrials.gov ID
- NCT06301243
- Acronym / sponsor ID
- FY24-62
- Conditions
- Metabolic Diseases, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Concordia University WisconsinUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactive | Experimental | Other: InactivitySubjects will be asked to be sedentary prior to an acute exercise bout (<5,000 steps as measured by a physical activity monitor). |
| Normal activity | Placebo comparator | Other: InactivitySubjects will be asked to have normal activity prior to an acute exercise bout (>8,500 steps as measured by a physical activity monitor). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- free from acute or chronic illness (cardiac, pulmonary, liver, or kidney abnormalities, cancer, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other known metabolic disorders)
- free from orthopedic limitations (including any artificial joints) no known lidocaine allergy
- do not currently smoke or participate in other forms of tobacco use.
- not currently in a structured exercise program
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InactivityAlso: SedentaryLow physical activity level prior to the exercise intervention. | Other | Inactive, Normal activity |
Primary outcome
Circulating lipid and carbohydrate metabolism
Time frame: Baseline; 20 and 40, and 60 minutes into exercise; and every 30 minutes after exercise up to 4 hours
Investigate the role of sex and inactivity on lipid and carbohydrate metabolism following a bout of aerobic exercise.
Basal and post-exercise gene expression with inactivity
Time frame: Baseline; 4 hours after exercise
Study the role of inactivity on basal and exercise-induced gene expression in skeletal muscle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivity in people with Metabolic Diseases and Aerobic Exercise, run by Concordia University Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating lipid and carbohydrate metabolism (time frame: Baseline; 20 and 40, and 60 minutes into exercise; and every 30 minutes after exercise up to 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.