An interventional study of Muscular Exercise in Sedentary Lifestyle, Hyperinsulinemia and Glucose Tolerance Impaired, sponsored by University of Houston. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by University of Houston · Not applicable, Interventional, and Basic science
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.
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Increased level of low effort muscular activity
Behavioral: Muscular Exercise
Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity
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
Time frame: 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
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.
Change in postprandial glucose regulation
Glucose concentration response during the postprandial period after an oral glucose tolerance test
Time frame: 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
Time frame: 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.
Time frame: Throughout the waking day (~16 hours).
Angiopoietin-like protein 4
One of the molecular determinants of lipoprotein lipase regulation
Time frame: The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
grams of the soleus, lateral gastrocnemius and medial gastrocnemius
Time frame: During acute contractile activity of at least 3 minutes
Electrical activity of muscle, Electromyography (EMG)
The activation of the triceps surae muscle group
Time frame: 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
Time frame: 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
Time frame: Acute responses within less than 24 hours.
Plasma insulin change
Plasma insulin concentration
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
Sedentary time is defined as sitting with a low rate of muscle metabolism due to inactivity
Time frame: Throughout the waking day (~16 hours).
apolipoprotein B100 concentration change
Biochemical measurement in units of mg per dL
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)
Nuclear magnetic resonance in units of umol per L
Time frame: After at least 4 weeks of increased contractile activity
Small dense LDL concentration change
This is an atherogenic lipoprotein particle
Time frame: 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
Time frame: After at least 4 weeks of increased contractile activity
Ferritin concentration change
This is a biomarker related to inflammation and diabetes
Time frame: After at least 4 weeks of increased contractile activity
Plasma triglyceride concentration change
Triglyceride concentration in VLDL and non-VLDL particles
Time frame: After at least 4 weeks of increased contractile activity
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.