Metabolic SyndromeNCT05885672
Improving the Early Detection of Cardiometabolic Disease Risk
An observational study of Metabolic Syndrome, run by University of Southern Mississippi at 1 site in United States.
Trial summary
The goal of this observational study is to reduce an individual's cardiometabolic disease risk by improving the ability to detect cardiometabolic disease risk in young adults through the use of novel technologies that increase access to and examine the utility of, a continuous metabolic syndrome severity score. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Online psychoeducational lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 31 Jul 2024
- Phase
- Observational
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults between the ages of 18 and 39 with or without metabolic syndrome
Who may be able to join
- adults between the ages of 18-39 years of age
Who cannot join
- Younger than 18 or older than 39
- Pregnant
- Breastfeeding or lactating
- Missing any limbs or part of a limb
- Having a substantial amount of metal implants (metal plates or complete joint replacements)
- Having a pacemaker or any other electrical implant
Show all 20Show fewer
- Type I diabetes
- Gestational diabetes
- Taking insulin
- Diagnosed heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease
- Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years
- Kidney disease
- Liver disease
- Thyroid disease
- Any diagnosed neurological or neurodegenerative diseases
- Having received ionizing radiation from a medical procedure within the last 30 days
- Being on a medically prescribed diet
- Having donated blood or plasma in the last 20 days prior to blood collection procedures
- Taking any supplements/medications that may interfere with the results of the study
- Any injury or physical impairment that would prevent performing any functional measures for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern Mississippi - School of Kinesiology and Nutrition
Hattiesburg, Mississippi, 39406
About this study
Official title: A Multi-Modal Approach to Improving the Early Detection of Cardiometabolic Disease Risk
The goal of this observational study is to reduce an individual's cardiometabolic disease risk by improving the ability to detect cardiometabolic disease risk in young adults through the use of novel technologies that increase access to and examine the utility of, a continuous metabolic syndrome severity score. An additional goal of this study is to understand the barriers to engagement in health-promoting behaviors and beliefs about interventions aimed at mitigating metabolic syndrome risk through a brief online lifestyle intervention.
The main question[s] it aims to answer are:
Read more
- Can a smartphone-based imaging system accurately predict a continuous metabolic syndrome severity score, in addition to other markers of cardiometabolic disease, in young adults?
- What is the relationship between autonomic dysfunction and metabolic syndrome severity in a cohort of young adults?
- What is the relationship between peripheral vascular dysfunction and metabolic syndrome severity in a cohort of young adults?
- What are the associations between metabolic syndrome severity and gait and functional ability in young adults using novel markerless motion capture technology?
- What are the attitudes and barriers towards lifestyle interventions targeted to reduce metabolic syndrome severity?
- What are the treatment-seeking and willingness to engage behaviors toward a webpage focused on lifestyle interventions to reduce metabolic syndrome severity?
Participants will be asked to undergo several assessments across four separate days which are design designed to determine the associations between cardiometabolic health markers and components of:
- body composition
- cardiovascular function
- functional ability
- attitudes and behaviors towards health-related interventions
- Conditions
- Metabolic Syndrome
- Being tested
- Online psychoeducational lifestyle intervention
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online psychoeducational lifestyle interventionBehavioural
A webpage-baed intervention focused on lifestyle interventions that aim to reduce metabolic syndrome severity.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults | Adults between the ages of 18 and 39 years Receives: Behavioral: Online psychoeducational lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Resting systolic and diastolic blood pressure
Measured: Baseline
Waist Circumference
Circumference of the waist measured by tape measure at the level of the iliac crest
Measured: Baseline
Fasting blood glucose
Blood glucose collected from capillary blood
Measured: Baseline
Blood lipids
Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood
Measured: Baseline
Metabolic syndrome severity score
A race and sex-specific equation that uses systolic blood pressure, waist circumference, and blood lipids to calculate a single continuous score that quantifies a person's overall cardiometabolic disease severity on a continuum where higher scores equal a worse outcome and negative scores equal a better outcome. The scale does not have bound and is infinite in positive and negative directions.
Measured: Baseline
Insulin
Insulin collected from intravenous blood
Measured: Baseline
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Equation that estimates insulin resistance from glucose and insulin measurements
Measured: Baseline
Tumor necrosis factor-alpha
Common biomarker of systemic inflammation collected from intravenous blood
Measured: Baseline
Body fat percentage
The percentage of body fat estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Measured: Baseline
Fat mass
The weight of fat mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Measured: Baseline
Fat-free mass
The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Measured: Baseline
Body circumferences
Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging
Measured: Baseline
Heart Rate Variability
Index of cardiac autonomic control collected via one-lead electrocardiogram
Measured: Baseline
Cardiac Baroreflex Sensitivity
Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography
Measured: Baseline
Flow-mediated changes in vascular diameter
Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Measured: Baseline
Flow-mediated changes in blood flow
Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Measured: Baseline
Flow-mediated changes in blood pressure
Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography
Measured: Baseline
Flow-mediated changes in vascular conductance
Changes in vascular conductance during 5 minutes of post-occlusive reactive hyperemia calculated as flow per unit of blood pressure
Measured: Baseline
Flow-mediated changes in vascular resistance
Changes in vascular resistance during 5 minutes of post-occlusive reactive hyperemia calculated as blood pressure per unit of flow
Measured: Baseline
Flow-mediated changes in skeletal muscle oxygenation
Changes in skeletal muscle oxygenated/deoxygenated hemoglobin saturation during 5 minutes of post-occlusive reactive hyperemia collected via near-infrared spectroscopy
Measured: Baseline
Passive Limb Movement Mediated Changes in Vascular Diameter
Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound
Measured: Baseline
Passive Limb Movement Mediated Changes in Blood Flow
Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound
Measured: Baseline
Passive Limb Movement Mediated Changes in Blood Pressure
Changes in blood pressure during passive limb movement collected via finger photoplethysmography
Measured: Baseline
Passive Limb Movement Mediated Changes in Vascular Conductance
Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure
Measured: Baseline
Passive Limb Movement Mediated Changes in Vascular Resistance
Changes in vascular resistance during passive limb movement calculated as the pressure per unit of flow
Measured: Baseline
Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation
Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy
Measured: Baseline
Carotid-Femoral Pulse Wave Velocity
Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis
Measured: Baseline
Cold Pressor Test Blood Pressure Responses
Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography
Measured: Baseline
Cold Pressor Test Heart Rate Responses
Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram
Measured: Baseline
Cold Pressor Test Vascular Conductance Responses
Changes in vascular conductance during three minutes of cold-pressor activation calculated as flow per unit of pressure
Measured: Baseline
Cold Pressor Test Vascular Resistance Responses
Changes in vascular resistance during three minutes of cold-pressor activation calculated as pressure per unit of flow
Measured: Baseline
Cold Pressor Test stroke volume Responses
Changes in stroke volume during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Measured: Baseline
Cold Pressor Test Cardiac Output Responses
Changes in cardiac output during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Measured: Baseline
Metaboreflex Blood Pressure Responses
Changes in blood pressure during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography
Measured: Baseline
Metaboreflex Heart Rate Responses
Changes in heart rate during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via one-lead electrocardiogram
Measured: Baseline
Metaboreflex Vascular Conductance Responses
Changes in vascular conductance during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) calculated as flow per unit of pressure
Measured: Baseline
Metaboreflex Vascular Resistance Responses
Changes in vascular resistance during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) calculated as pressure per unit of flow
Measured: Baseline
Metaboreflex Stroke Volume Responses
Changes in stroke volume during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography or duplex Doppler ultrasound
Measured: Baseline
Metaboreflex Cardiac Output Responses
Changes in cardiac output during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography or duplex Doppler ultrasound
Measured: Baseline
Functional Sympatholysis Blood Flow Responses
Changes in limb blood flow during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Collected via finger photoplethysmography
Measured: Baseline
Functional Sympatholysis Vascular Conductance Responses
Changes in vascular conductance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise calculated as flow per unit of pressure
Measured: Baseline
Functional Sympatholysis Vascular Resistance Responses
Changes in vascular resistance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Calculated as pressure per unit of flow
Measured: Baseline
Functional Sympatholysis Blood Pressure Responses
Changes in blood pressure during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise collected via finger photoplethysmography
Measured: Baseline
Gait velocity
Self-selected walking velocity over level ground measured with a timing gate system.
Measured: Baseline
Gait velocity
Self-selected walking velocity over level ground measured with a timing gate system.
Measured: Immediately post 6-minute walk test
Stride Length
Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Measured: Baseline
Stride Length
Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Stride Width
Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Measured: Baseline
Stride Width
Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Gait Cadence
Steps taken per minute measured with a motion capture system.
Measured: Baseline
Gait Cadence
Steps taken per minute measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Ankle joint angle
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Measured: Baseline
Ankle joint moment
Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.
Measured: Baseline
Ankle joint angle
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Ankle joint moment
Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Knee joint angle
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Measured: Baseline
Knee joint moment
Knee moment during level ground walking measured in newton-meters measured with a motion capture system.
Measured: Baseline
Knee joint angle
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Knee joint moment
Knee moment during level ground walking measured in newton-meters measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Hip joint angle
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Measured: Baseline
Hip joint moment
Hip moment during level ground walking measured in newton-meters measured with a motion capture system.
Measured: Baseline
Hip joint angle
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Hip joint moment
Hip moment during level ground walking measured in newton-meters measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Ground reaction forces
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Measured: Baseline
Ground reaction forces
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Measured: Immediately post 6-minute walk test
Center of pressure - right leg
Whole body center of pressure displacement
Measured: Baseline
Center of pressure - left leg
Whole body center of pressure displacement
Measured: Baseline
Center of pressure - bilateral
Whole body center of pressure displacement
Measured: Baseline
Timed-up and go
Time (seconds) for participant to stand up from chair, walk 3 meters, and return
Measured: Baseline
Sit-to-stand
Time (seconds) for participant to stand up from chair and sit back down (5 repetitions)
Measured: Baseline
Time Up and Down Stairs
Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs
Measured: Baseline
Isometric strength
Isometric muscle strength of hip flexors and extensors, knee flexors and extensors, and ankle dorsi- and plantar flexors of the right leg
Measured: Baseline
Visceral adipose tissue
Absolute fat-mass around the visceral organs in kilograms measured using dual-energy x-ray absorptiometry and near-infrared reactance spectroscopy
Measured: Baseline
Subcutaneous adipose tissue
Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry
Measured: Baseline
Motivation and Attitudes Towards Health
Motivation and Attitudes Towards Changing Health Scale. Scores range from 5-45, which higher scores indicating higher motivation and more positive attitudes towards changing health behavior
Measured: Baseline
Readiness for Behavior Change
Readiness for Change Questionnaire. Separate subscales are calculated for each of the 5 stages of change (pre-contemplation, contemplation, preparation, action, maintenance) with higher scores indicating a greater likelihood of an individual being in that stage of change versus another. The 12 items on this scale are scored on a scale of -2 to +2 (-2 = Strongly disagree, -1 Disagree, 0 = Unsure, +1 = Agree, +2 = Strongly Agree).
Measured: Baseline
Treatment Seeking Behavior
Whether participant engages with educational webpage about health behavior change. This is a dichotomous yes/no value based on whether someone clicks on the webpage or not.
Measured: Baseline
Secondary outcomes (2)
Height
Height collected using a stadiometer
Measured: Baseline
Weight
Weight collected using a stadiometer
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start11 Sep 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center
- Responsible party
- Sponsor
- Investigators
- Austin J Graybeal, PhD, Principal investigator, University of Southern MississippiJon Stavres, PhD, Principal investigator, University of Southern MississippiTanner Thorsen, PhD, Principal investigator, University of Southern MississippiMegan Renna, PhD, Principal investigator, University of Southern Mississippi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885672
- Sponsor's protocol ID
- 23-0446
- Status last verified
- May 2024
- First submitted
- 10 May 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data and analytic code to be made available using Open Science Framework
Publications
Graybeal AJ, Compton AT, Swafford SH, Brandner CF, Thorsen T, Renna ME, Stavres J. Measurements of Abdominal Obesity are Associated with Metabolic Syndrome Severity Independent of Hypertensive Phenotype in White but not Black Young Adults. J Racial Ethn Health Disparities. 2025 Aug;12(4):2299-2311. doi: 10.1007/s40615-024-02051-8. Epub 2024 Jun 20.
PubMed 38902464
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Modal Approach to Improving the Early Detection of Cardiometabolic Disease Risk
- ClinicalTrials.gov ID
- NCT05885672
- Acronym / sponsor ID
- 23-0446
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 2 Jun 2023 (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.
The goal of this observational study is to reduce an individual's cardiometabolic disease risk by improving the ability to detect cardiometabolic disease risk in young adults through the use of novel technologies that increase access to and examine the utility of, a continuous metabolic syndrome severity score. An additional goal of this study is to understand the barriers to engagement in health-promoting behaviors and beliefs about interventions aimed at mitigating metabolic syndrome risk through a brief online lifestyle intervention.
The main question[s] it aims to answer are:
- Can a smartphone-based imaging system accurately predict a continuous metabolic syndrome severity score, in addition to other markers of cardiometabolic disease, in young adults?
- What is the relationship between autonomic dysfunction and metabolic syndrome severity in a cohort of young adults?
- What is the relationship between peripheral vascular dysfunction and metabolic syndrome severity in a cohort of young adults?
- What are the associations between metabolic syndrome severity and gait and functional ability in young adults using novel markerless motion capture technology?
- What are the attitudes and barriers towards lifestyle interventions targeted to reduce metabolic syndrome severity?
- What are the treatment-seeking and willingness to engage behaviors toward a webpage focused on lifestyle interventions to reduce metabolic syndrome severity?
Participants will be asked to undergo several assessments across four separate days which are design designed to determine the associations between cardiometabolic health markers and components of:
- body composition
- cardiovascular function
- functional ability
- attitudes and behaviors towards health-related interventions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Adults | – | Behavioral: Online psychoeducational lifestyle interventionAdults between the ages of 18 and 39 years |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults between the ages of 18 and 39 with or without metabolic syndrome
Key inclusion criteria (1 listed)
- adults between the ages of 18-39 years of age
Key exclusion criteria (20 listed)
- Younger than 18 or older than 39
- Pregnant
- Breastfeeding or lactating
- Missing any limbs or part of a limb
- Having a substantial amount of metal implants (metal plates or complete joint replacements)
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 |
|---|---|---|
| Online psychoeducational lifestyle interventionA webpage-baed intervention focused on lifestyle interventions that aim to reduce metabolic syndrome severity. | Behavioural | Young Adults |
Primary outcome
Blood Pressure
Time frame: Baseline
Resting systolic and diastolic blood pressure
Waist Circumference
Time frame: Baseline
Circumference of the waist measured by tape measure at the level of the iliac crest
Fasting blood glucose
Time frame: Baseline
Blood glucose collected from capillary blood
Blood lipids
Time frame: Baseline
Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood
Metabolic syndrome severity score
Time frame: Baseline
A race and sex-specific equation that uses systolic blood pressure, waist circumference, and blood lipids to calculate a single continuous score that quantifies a person's overall cardiometabolic disease severity on a continuum where higher scores equal a worse outcome and negative scores equal a better outcome. The scale does not have bound and is infinite in positive and negative directions.
Insulin
Time frame: Baseline
Insulin collected from intravenous blood
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline
Equation that estimates insulin resistance from glucose and insulin measurements
Tumor necrosis factor-alpha
Time frame: Baseline
Common biomarker of systemic inflammation collected from intravenous blood
Body fat percentage
Time frame: Baseline
The percentage of body fat estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Fat mass
Time frame: Baseline
The weight of fat mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Fat-free mass
Time frame: Baseline
The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Body circumferences
Time frame: Baseline
Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging
Heart Rate Variability
Time frame: Baseline
Index of cardiac autonomic control collected via one-lead electrocardiogram
Cardiac Baroreflex Sensitivity
Time frame: Baseline
Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography
Flow-mediated changes in vascular diameter
Time frame: Baseline
Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Flow-mediated changes in blood flow
Time frame: Baseline
Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Flow-mediated changes in blood pressure
Time frame: Baseline
Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography
Flow-mediated changes in vascular conductance
Time frame: Baseline
Changes in vascular conductance during 5 minutes of post-occlusive reactive hyperemia calculated as flow per unit of blood pressure
Flow-mediated changes in vascular resistance
Time frame: Baseline
Changes in vascular resistance during 5 minutes of post-occlusive reactive hyperemia calculated as blood pressure per unit of flow
Flow-mediated changes in skeletal muscle oxygenation
Time frame: Baseline
Changes in skeletal muscle oxygenated/deoxygenated hemoglobin saturation during 5 minutes of post-occlusive reactive hyperemia collected via near-infrared spectroscopy
Passive Limb Movement Mediated Changes in Vascular Diameter
Time frame: Baseline
Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound
Passive Limb Movement Mediated Changes in Blood Flow
Time frame: Baseline
Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound
Passive Limb Movement Mediated Changes in Blood Pressure
Time frame: Baseline
Changes in blood pressure during passive limb movement collected via finger photoplethysmography
Passive Limb Movement Mediated Changes in Vascular Conductance
Time frame: Baseline
Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure
Passive Limb Movement Mediated Changes in Vascular Resistance
Time frame: Baseline
Changes in vascular resistance during passive limb movement calculated as the pressure per unit of flow
Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation
Time frame: Baseline
Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy
Carotid-Femoral Pulse Wave Velocity
Time frame: Baseline
Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis
Cold Pressor Test Blood Pressure Responses
Time frame: Baseline
Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography
Cold Pressor Test Heart Rate Responses
Time frame: Baseline
Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram
Cold Pressor Test Vascular Conductance Responses
Time frame: Baseline
Changes in vascular conductance during three minutes of cold-pressor activation calculated as flow per unit of pressure
Cold Pressor Test Vascular Resistance Responses
Time frame: Baseline
Changes in vascular resistance during three minutes of cold-pressor activation calculated as pressure per unit of flow
Cold Pressor Test stroke volume Responses
Time frame: Baseline
Changes in stroke volume during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Cold Pressor Test Cardiac Output Responses
Time frame: Baseline
Changes in cardiac output during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Metaboreflex Blood Pressure Responses
Time frame: Baseline
Changes in blood pressure during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography
Metaboreflex Heart Rate Responses
Time frame: Baseline
Changes in heart rate during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via one-lead electrocardiogram
Metaboreflex Vascular Conductance Responses
Time frame: Baseline
Changes in vascular conductance during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) calculated as flow per unit of pressure
Metaboreflex Vascular Resistance Responses
Time frame: Baseline
Changes in vascular resistance during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) calculated as pressure per unit of flow
Metaboreflex Stroke Volume Responses
Time frame: Baseline
Changes in stroke volume during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography or duplex Doppler ultrasound
Metaboreflex Cardiac Output Responses
Time frame: Baseline
Changes in cardiac output during rhythmic handgrip exercise with graded blood flow restriction (minutes 0, 2, 4, 6, and 8) collected via finger photoplethysmography or duplex Doppler ultrasound
Functional Sympatholysis Blood Flow Responses
Time frame: Baseline
Changes in limb blood flow during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Collected via finger photoplethysmography
Functional Sympatholysis Vascular Conductance Responses
Time frame: Baseline
Changes in vascular conductance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise calculated as flow per unit of pressure
Functional Sympatholysis Vascular Resistance Responses
Time frame: Baseline
Changes in vascular resistance during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Calculated as pressure per unit of flow
Functional Sympatholysis Blood Pressure Responses
Time frame: Baseline
Changes in blood pressure during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise collected via finger photoplethysmography
Gait velocity
Time frame: Baseline
Self-selected walking velocity over level ground measured with a timing gate system.
Gait velocity
Time frame: Immediately post 6-minute walk test
Self-selected walking velocity over level ground measured with a timing gate system.
Stride Length
Time frame: Baseline
Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Stride Length
Time frame: Immediately post 6-minute walk test
Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Stride Width
Time frame: Baseline
Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Stride Width
Time frame: Immediately post 6-minute walk test
Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Gait Cadence
Time frame: Baseline
Steps taken per minute measured with a motion capture system.
Gait Cadence
Time frame: Immediately post 6-minute walk test
Steps taken per minute measured with a motion capture system.
Ankle joint angle
Time frame: Baseline
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Ankle joint moment
Time frame: Baseline
Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.
Ankle joint angle
Time frame: Immediately post 6-minute walk test
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Ankle joint moment
Time frame: Immediately post 6-minute walk test
Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.
Knee joint angle
Time frame: Baseline
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Knee joint moment
Time frame: Baseline
Knee moment during level ground walking measured in newton-meters measured with a motion capture system.
Knee joint angle
Time frame: Immediately post 6-minute walk test
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Knee joint moment
Time frame: Immediately post 6-minute walk test
Knee moment during level ground walking measured in newton-meters measured with a motion capture system.
Hip joint angle
Time frame: Baseline
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Hip joint moment
Time frame: Baseline
Hip moment during level ground walking measured in newton-meters measured with a motion capture system.
Hip joint angle
Time frame: Immediately post 6-minute walk test
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Hip joint moment
Time frame: Immediately post 6-minute walk test
Hip moment during level ground walking measured in newton-meters measured with a motion capture system.
Ground reaction forces
Time frame: Baseline
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Ground reaction forces
Time frame: Immediately post 6-minute walk test
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Center of pressure - right leg
Time frame: Baseline
Whole body center of pressure displacement
Center of pressure - left leg
Time frame: Baseline
Whole body center of pressure displacement
Center of pressure - bilateral
Time frame: Baseline
Whole body center of pressure displacement
Timed-up and go
Time frame: Baseline
Time (seconds) for participant to stand up from chair, walk 3 meters, and return
Sit-to-stand
Time frame: Baseline
Time (seconds) for participant to stand up from chair and sit back down (5 repetitions)
Time Up and Down Stairs
Time frame: Baseline
Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs
Isometric strength
Time frame: Baseline
Isometric muscle strength of hip flexors and extensors, knee flexors and extensors, and ankle dorsi- and plantar flexors of the right leg
Visceral adipose tissue
Time frame: Baseline
Absolute fat-mass around the visceral organs in kilograms measured using dual-energy x-ray absorptiometry and near-infrared reactance spectroscopy
Subcutaneous adipose tissue
Time frame: Baseline
Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry
Motivation and Attitudes Towards Health
Time frame: Baseline
Motivation and Attitudes Towards Changing Health Scale. Scores range from 5-45, which higher scores indicating higher motivation and more positive attitudes towards changing health behavior
Readiness for Behavior Change
Time frame: Baseline
Readiness for Change Questionnaire. Separate subscales are calculated for each of the 5 stages of change (pre-contemplation, contemplation, preparation, action, maintenance) with higher scores indicating a greater likelihood of an individual being in that stage of change versus another. The 12 items on this scale are scored on a scale of -2 to +2 (-2 = Strongly disagree, -1 Disagree, 0 = Unsure, +1 = Agree, +2 = Strongly Agree).
Treatment Seeking Behavior
Time frame: Baseline
Whether participant engages with educational webpage about health behavior change. This is a dichotomous yes/no value based on whether someone clicks on the webpage or not.
2 secondary outcomes
Height
Time frame: Baseline
Weight
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 38902464Graybeal AJ, Compton AT, Swafford SH, Brandner CF, Thorsen T, Renna ME, Stavres J. Measurements of Abdominal Obesity are Associated with Metabolic Syndrome Severity Independent of Hypertensive Phenotype in White but not Black Young Adults. J Racial Ethn Health Disparities. 2025 Aug;12(4):2299-2311. doi: 10.1007/s40615-024-02051-8. Epub 2024 Jun 20.
- Individual participant dataSharing planned: Yes. Deidentified study data and analytic code to be made available using Open Science Framework
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Austin J Graybeal, PhD principal investigator
University of Southern Mississippi
Jon Stavres, PhD principal investigator
University of Southern Mississippi
Tanner Thorsen, PhD principal investigator
University of Southern Mississippi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by University of Southern Mississippi 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 1 inclusion and 20 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 9 Jul 2024. 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?
Blood Pressure (time frame: Baseline). The study lists 77 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885672, which also lists 1 linked publication.
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 9 Jul 2024.