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Developing a Physiological Understanding of High Duration Activity

Primary Purpose

Sedentary Lifestyle, Hyperinsulinemia, Glucose Tolerance Impaired

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Muscular Exercise
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sedentary Lifestyle focused on measuring sedentary, physical activity, muscle contractile activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscular Exercise

Arm Description

Increased level of low effort muscular activity

Outcomes

Primary Outcome Measures

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
Fatigue time during muscle group specific contractile activity
Determinants of muscular endurance as a function of recruitment intensity
Change in postprandial glucose regulation
Glucose concentration response during the postprandial period after an oral glucose tolerance test
Change in very low density lipoprotein (VLDL) - Triglyceride
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
Development of an objective method(s) to quantify sedentary vs. non sedentary time.
Angiopoietin-like protein 4
One of the molecular determinants of lipoprotein lipase regulation

Secondary Outcome Measures

Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
grams of the soleus, lateral gastrocnemius and medial gastrocnemius
Electrical activity of muscle, Electromyography (EMG)
The activation of the triceps surae muscle group
Local rate of oxygen consumption of working muscle
oxygen cost per kg muscle during isolated contractile activity and treadmill exercise
The ratio of carbohydrate vs. fat oxidation
The change in the ratio of the fat vs. carbohydrate utilization during acute contractile activity
Plasma insulin change
Plasma insulin concentration
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
apolipoprotein B100 concentration change
Biochemical measurement in units of mg per dL
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
Small dense LDL concentration change
This is an atherogenic lipoprotein particle
Complement component 3 (C3) concentration change
This is an acute phase protein, a marker of inflammation
Ferritin concentration change
This is a biomarker related to inflammation and diabetes
Plasma triglyceride concentration change
Triglyceride concentration in VLDL and non-VLDL particles

Full Information

First Posted
April 16, 2019
Last Updated
May 18, 2023
Sponsor
University of Houston
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT05135234
Brief Title
Developing a Physiological Understanding of High Duration Activity
Official Title
Adaptive Effects of Very Light Physical Activity on Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Hyperinsulinemia, Glucose Tolerance Impaired, Low-density-lipoprotein-type, Aging Problems, Lipid Metabolism Disorders, Inactivity, Physical, Metabolic Disorder, Glucose
Keywords
sedentary, physical activity, muscle contractile activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Muscular Exercise
Arm Type
Experimental
Arm Description
Increased level of low effort muscular activity
Intervention Type
Behavioral
Intervention Name(s)
Muscular Exercise
Intervention Description
Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity
Primary Outcome Measure Information:
Title
Oxygen cost of isolated muscle contractions
Description
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)
Title
Fatigue time during muscle group specific contractile activity
Description
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.
Title
Change in postprandial glucose regulation
Description
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
Title
Change in very low density lipoprotein (VLDL) - Triglyceride
Description
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
Title
The change in muscular inactivity time as a result of isolated contractile activity of the soleus
Description
Development of an objective method(s) to quantify sedentary vs. non sedentary time.
Time Frame
Throughout the waking day (~16 hours).
Title
Angiopoietin-like protein 4
Description
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
Secondary Outcome Measure Information:
Title
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
Description
grams of the soleus, lateral gastrocnemius and medial gastrocnemius
Time Frame
During acute contractile activity of at least 3 minutes
Title
Electrical activity of muscle, Electromyography (EMG)
Description
The activation of the triceps surae muscle group
Time Frame
At least 3 minute recording periods
Title
Local rate of oxygen consumption of working muscle
Description
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
Title
The ratio of carbohydrate vs. fat oxidation
Description
The change in the ratio of the fat vs. carbohydrate utilization during acute contractile activity
Time Frame
Acute responses within less than 24 hours.
Title
Plasma insulin change
Description
Plasma insulin concentration
Time Frame
The change through the completion of the postprandial period, an average of 180 minutes
Title
Sedentary/muscular inactivity time vs. intermittent non-seated standing behaviors
Description
Sedentary time is defined as sitting with a low rate of muscle metabolism due to inactivity
Time Frame
Throughout the waking day (~16 hours).
Title
apolipoprotein B100 concentration change
Description
Biochemical measurement in units of mg per dL
Time Frame
After at least 4 weeks of increased contractile activity
Title
Change in the concentration of GlycA (this is not an acronym; it is a biomarker of inflammation)
Description
Nuclear magnetic resonance in units of umol per L
Time Frame
After at least 4 weeks of increased contractile activity
Title
Small dense LDL concentration change
Description
This is an atherogenic lipoprotein particle
Time Frame
After at least 4 weeks of increased contractile activity
Title
Complement component 3 (C3) concentration change
Description
This is an acute phase protein, a marker of inflammation
Time Frame
After at least 4 weeks of increased contractile activity
Title
Ferritin concentration change
Description
This is a biomarker related to inflammation and diabetes
Time Frame
After at least 4 weeks of increased contractile activity
Title
Plasma triglyceride concentration change
Description
Triglyceride concentration in VLDL and non-VLDL particles
Time Frame
After at least 4 weeks of increased contractile activity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc T Hamilton, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Developing a Physiological Understanding of High Duration Activity

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