Sedentary LifestyleNCT05135234
Developing a Physiological Understanding of High Duration Activity
A study testing Muscular Exercise in people with Sedentary Lifestyle and Hyperinsulinemia, run by University of Houston at 1 site in United States.
Trial summary
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Hyperinsulinemia, Glucose Tolerance Impaired
- What is being tested?
- Muscular Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age must be 18 years or older
- Able to fast overnight
- Can maintain diet, medications, and sleep habits between each of the testing visits.
- Lifestyle is consistent with participation in a study evaluating reductions of inactivity (defined by sitting at a low metabolic rate because of minimal muscular activity)
- Willing and able to wear small wearable activity monitors under their clothes as instructed.
- No plans to start a new diet or exercise program if enrolled in the present study.
Who cannot join
- Practical barriers to completing the study, such as plans to move, or work, or family commitments.
- Plans to change lifestyle during the present study.
- Have physical, vocational, or reasons that prohibit ordinary sitting behaviors present in the modern world.
- Currently dieting to change body weight, or have eating disorder.
- Are pregnant or plan to become pregnant.
- Taking medications that affect bleeding (ie anticoagulants).
- Allergy to lidocaine excludes biopsy component of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Effects of Very Light Physical Activity on Metabolism
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging.
From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day).
Read more
Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time.
This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement.
There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.
Read the detailed description
Physical activity/inactivity will be carefully measured with objective devices. Wearable devices most commonly include accelerometers capable of capturing various types of movement and body posture. The intensity of muscle activation (the soleus and other leg muscles) will be measured in some participants in the developmental studies with EMG, with the limb motion quantified with goniometry. Skeletal muscle and whole body metabolism will be evaluated, especially after isolated local contractile activity focusing on the slow oxidative soleus muscle. Blood chemistry will also be investigated in this comprehensive series of studies to understand how replacing sedentary time with low effort muscular activity can be enhanced. Glycemia will be evaluated in the postprandial period in the morning after an overnight fast when there can be standardized control of carbohydrate ingestion. This includes a standardized oral glucose tolerance test with careful experimental assessment of posture and muscular recruitment during the testing periods. One phase of this study is particularly interested in assessing the acute responses that occur immediately as a result of contractile activity, while also evaluating in another phase how this may be impacted by a change in the sedentary lifestyle. This includes assessing new approaches for improving metabolism throughout the day by reducing the amount of time sitting inactive (i.e. sedentary time). Importantly, because the potential immediate benefits of muscle contractile activity are directly dependent on the duration of activity, the investigators aim to develop in a series of experiments how much muscular activity time can be performed comfortably and safely by anybody instead of sitting inactive with low muscle metabolism regardless of age, fitness, body type, and other conditions commonly limiting effectiveness of traditional exercise prescriptions.
- Conditions
- Sedentary Lifestyle, Hyperinsulinemia, Glucose Tolerance Impaired, Low-density-lipoprotein-type, Aging Problems, Lipid Metabolism Disorders
- Being tested
- Muscular Exercise
- Keywords
- sedentary, physical activity, muscle contractile activity
- Medical subject headings
- Sedentary Behavior, Hyperinsulinism, Glucose Intolerance, Lipid Metabolism Disorders, Glucose Metabolism Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular ExerciseBehavioural
Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity
| Study group | Role | What they receive |
|---|---|---|
| Muscular Exercise | Experimental | Increased level of low effort muscular activity Receives: Behavioral: Muscular Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen cost of isolated muscle contractions
The energetics of isolated muscle contractions will be described relative to the distinct biomechanics of different types of muscular movement
Measured: Acute contractile activity (at least 3 minutes)
Fatigue time during muscle group specific contractile activity
Determinants of muscular endurance as a function of recruitment intensity
Measured: Acute measurements less than 1 day. The exact duration is an individual response that is an outcome of unknown minutes consistent with the fatiguability of different movements.
Change in postprandial glucose regulation
Glucose concentration response during the postprandial period after an oral glucose tolerance test
Measured: The change through the completion of the postprandial period, an average of 180 minutes
Change in very low density lipoprotein (VLDL) - Triglyceride
The concentration of triglyceride in the plasma VLDL lipoprotein
Measured: The change through the completion of an acute fasting period, approximately 8-12 hours
The change in muscular inactivity time as a result of isolated contractile activity of the soleus
Development of an objective method(s) to quantify sedentary vs. non sedentary time.
Measured: Throughout the waking day (~16 hours).
Angiopoietin-like protein 4
One of the molecular determinants of lipoprotein lipase regulation
Measured: The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
Secondary outcomes (12)
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
grams of the soleus, lateral gastrocnemius and medial gastrocnemius
Measured: During acute contractile activity of at least 3 minutes
Electrical activity of muscle, Electromyography (EMG)
The activation of the triceps surae muscle group
Measured: At least 3 minute recording periods
Local rate of oxygen consumption of working muscle
oxygen cost per kg muscle during isolated contractile activity and treadmill exercise
Measured: Steady-state measurements taken for ~6 continuous minutes of contractile activity
The ratio of carbohydrate vs. fat oxidation
The change in the ratio of the fat vs. carbohydrate utilization during acute contractile activity
Measured: Acute responses within less than 24 hours.
Plasma insulin change
Plasma insulin concentration
Measured: The change through the completion of the postprandial period, an average of 180 minutes
Sedentary/muscular inactivity time vs. intermittent non-seated standing behaviors
Sedentary time is defined as sitting with a low rate of muscle metabolism due to inactivity
Measured: Throughout the waking day (~16 hours).
apolipoprotein B100 concentration change
Biochemical measurement in units of mg per dL
Measured: After at least 4 weeks of increased contractile activity
Change in the concentration of GlycA (this is not an acronym; it is a biomarker of inflammation)
Nuclear magnetic resonance in units of umol per L
Measured: After at least 4 weeks of increased contractile activity
Small dense LDL concentration change
This is an atherogenic lipoprotein particle
Measured: After at least 4 weeks of increased contractile activity
Complement component 3 (C3) concentration change
This is an acute phase protein, a marker of inflammation
Measured: After at least 4 weeks of increased contractile activity
Ferritin concentration change
This is a biomarker related to inflammation and diabetes
Measured: After at least 4 weeks of increased contractile activity
Plasma triglyceride concentration change
Triglyceride concentration in VLDL and non-VLDL particles
Measured: After at least 4 weeks of increased contractile activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study startAug 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Marc Hamilton, University of Houston
- Investigators
- Marc T Hamilton, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135234
- Sponsor's protocol ID
- 15463-01
- Other IDs
- University of Houston
- Status last verified
- May 2023
- First submitted
- 16 Apr 2019
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Effects of Very Light Physical Activity on Metabolism
- ClinicalTrials.gov ID
- NCT05135234
- Acronym / sponsor ID
- 15463-01
- Conditions
- Sedentary Lifestyle, Hyperinsulinemia, Glucose Tolerance Impaired, Low-density-lipoprotein-type, Aging Problems, Lipid Metabolism Disorders
- Keywords
- sedentary, physical activity, muscle contractile activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Nov 2021 (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.
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging.
From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day).
Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time.
This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement.
There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.
Detailed description
Physical activity/inactivity will be carefully measured with objective devices. Wearable devices most commonly include accelerometers capable of capturing various types of movement and body posture. The intensity of muscle activation (the soleus and other leg muscles) will be measured in some participants in the developmental studies with EMG, with the limb motion quantified with goniometry. Skeletal muscle and whole body metabolism will be evaluated, especially after isolated local contractile activity focusing on the slow oxidative soleus muscle. Blood chemistry will also be investigated in this comprehensive series of studies to understand how replacing sedentary time with low effort muscular activity can be enhanced. Glycemia will be evaluated in the postprandial period in the morning after an overnight fast when there can be standardized control of carbohydrate ingestion. This includes a standardized oral glucose tolerance test with careful experimental assessment of posture and muscular recruitment during the testing periods. One phase of this study is particularly interested in assessing the acute responses that occur immediately as a result of contractile activity, while also evaluating in another phase how this may be impacted by a change in the sedentary lifestyle. This includes assessing new approaches for improving metabolism throughout the day by reducing the amount of time sitting inactive (i.e. sedentary time). Importantly, because the potential immediate benefits of muscle contractile activity are directly dependent on the duration of activity, the investigators aim to develop in a series of experiments how much muscular activity time can be performed comfortably and safely by anybody instead of sitting inactive with low muscle metabolism regardless of age, fitness, body type, and other conditions commonly limiting effectiveness of traditional exercise prescriptions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscular Exercise | Experimental | Behavioral: Muscular ExerciseIncreased level of low effort muscular activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age must be 18 years or older
- Able to fast overnight
- Can maintain diet, medications, and sleep habits between each of the testing visits.
- Lifestyle is consistent with participation in a study evaluating reductions of inactivity (defined by sitting at a low metabolic rate because of minimal muscular activity)
- Willing and able to wear small wearable activity monitors under their clothes as instructed.
Key exclusion criteria (7 listed)
- Practical barriers to completing the study, such as plans to move, or work, or family commitments.
- Plans to change lifestyle during the present study.
- Have physical, vocational, or reasons that prohibit ordinary sitting behaviors present in the modern world.
- Currently dieting to change body weight, or have eating disorder.
- Are pregnant or plan to become pregnant.
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 |
|---|---|---|
| Muscular ExerciseSedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity | Behavioural | Muscular Exercise |
Primary outcome
Oxygen cost of isolated muscle contractions
Time frame: Acute contractile activity (at least 3 minutes)
The energetics of isolated muscle contractions will be described relative to the distinct biomechanics of different types of muscular movement
Fatigue time during muscle group specific contractile activity
Time frame: Acute measurements less than 1 day. The exact duration is an individual response that is an outcome of unknown minutes consistent with the fatiguability of different movements.
Determinants of muscular endurance as a function of recruitment intensity
Change in postprandial glucose regulation
Time frame: The change through the completion of the postprandial period, an average of 180 minutes
Glucose concentration response during the postprandial period after an oral glucose tolerance test
Change in very low density lipoprotein (VLDL) - Triglyceride
Time frame: The change through the completion of an acute fasting period, approximately 8-12 hours
The concentration of triglyceride in the plasma VLDL lipoprotein
The change in muscular inactivity time as a result of isolated contractile activity of the soleus
Time frame: Throughout the waking day (~16 hours).
Development of an objective method(s) to quantify sedentary vs. non sedentary time.
Angiopoietin-like protein 4
Time frame: The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
One of the molecular determinants of lipoprotein lipase regulation
12 secondary outcomes
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
Time frame: During acute contractile activity of at least 3 minutes
Electrical activity of muscle, Electromyography (EMG)
Time frame: At least 3 minute recording periods
Local rate of oxygen consumption of working muscle
Time frame: Steady-state measurements taken for ~6 continuous minutes of contractile activity
The ratio of carbohydrate vs. fat oxidation
Time frame: Acute responses within less than 24 hours.
Plasma insulin change
Time frame: The change through the completion of the postprandial period, an average of 180 minutes
Sedentary/muscular inactivity time vs. intermittent non-seated standing behaviors
Time frame: Throughout the waking day (~16 hours).
apolipoprotein B100 concentration change
Time frame: After at least 4 weeks of increased contractile activity
Change in the concentration of GlycA (this is not an acronym; it is a biomarker of inflammation)
Time frame: After at least 4 weeks of increased contractile activity
Small dense LDL concentration change
Time frame: After at least 4 weeks of increased contractile activity
Complement component 3 (C3) concentration change
Time frame: After at least 4 weeks of increased contractile activity
Ferritin concentration change
Time frame: After at least 4 weeks of increased contractile activity
Plasma triglyceride concentration change
Time frame: After at least 4 weeks of increased contractile activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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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.
Marc T Hamilton, Ph.D. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscular Exercise in people with Sedentary Lifestyle and Hyperinsulinemia, run by University of Houston 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 May 2023. 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. 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?
Results are not available in the source record.
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?
Oxygen cost of isolated muscle contractions (time frame: Acute contractile activity (at least 3 minutes)). The study lists 6 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 May 2023.