An observational study in Metabolic Syndrome, sponsored by University of Southern Mississippi. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University of Southern Mississippi · Observational
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:
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:
1,964 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 458 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Southern Mississippi is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Young adults between the ages of 18 and 39 with or without metabolic syndrome
Exclusion Criteria:
Adults between the ages of 18 and 39 years
Behavioral: Online psychoeducational lifestyle intervention
A webpage-baed intervention focused on lifestyle interventions that aim to reduce metabolic syndrome severity.
Blood Pressure
Resting systolic and diastolic blood pressure
Time frame: Baseline
Waist Circumference
Circumference of the waist measured by tape measure at the level of the iliac crest
Time frame: Baseline
Fasting blood glucose
Blood glucose collected from capillary blood
Time frame: Baseline
Blood lipids
Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood
Time frame: 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.
Time frame: Baseline
Insulin
Insulin collected from intravenous blood
Time frame: Baseline
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Equation that estimates insulin resistance from glucose and insulin measurements
Time frame: Baseline
Tumor necrosis factor-alpha
Common biomarker of systemic inflammation collected from intravenous blood
Time frame: Baseline
Body fat percentage
The percentage of body fat estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Time frame: Baseline
Fat mass
The weight of fat mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Time frame: Baseline
Fat-free mass
The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Time frame: Baseline
Body circumferences
Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging
Time frame: Baseline
Heart Rate Variability
Index of cardiac autonomic control collected via one-lead electrocardiogram
Time frame: Baseline
Cardiac Baroreflex Sensitivity
Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography
Time frame: Baseline
Flow-mediated changes in vascular diameter
Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Time frame: Baseline
Flow-mediated changes in blood flow
Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Time frame: Baseline
Flow-mediated changes in blood pressure
Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Passive Limb Movement Mediated Changes in Vascular Diameter
Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound
Time frame: Baseline
Passive Limb Movement Mediated Changes in Blood Flow
Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound
Time frame: Baseline
Passive Limb Movement Mediated Changes in Blood Pressure
Changes in blood pressure during passive limb movement collected via finger photoplethysmography
Time frame: Baseline
Passive Limb Movement Mediated Changes in Vascular Conductance
Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure
Time frame: 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
Time frame: Baseline
Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation
Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy
Time frame: Baseline
Carotid-Femoral Pulse Wave Velocity
Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis
Time frame: Baseline
Cold Pressor Test Blood Pressure Responses
Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography
Time frame: Baseline
Cold Pressor Test Heart Rate Responses
Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Gait velocity
Self-selected walking velocity over level ground measured with a timing gate system.
Time frame: Baseline
Gait velocity
Self-selected walking velocity over level ground measured with a timing gate system.
Time frame: 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.
Time frame: Baseline
Stride Length
Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Time frame: 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.
Time frame: Baseline
Stride Width
Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Time frame: Immediately post 6-minute walk test
Gait Cadence
Steps taken per minute measured with a motion capture system.
Time frame: Baseline
Gait Cadence
Steps taken per minute measured with a motion capture system.
Time frame: Immediately post 6-minute walk test
Ankle joint angle
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Time frame: Baseline
Ankle joint moment
Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.
Time frame: Baseline
Ankle joint angle
Ankle angle during level ground walking measured in degrees measured with a motion capture system.
Time frame: 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.
Time frame: Immediately post 6-minute walk test
Knee joint angle
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Time frame: Baseline
Knee joint moment
Knee moment during level ground walking measured in newton-meters measured with a motion capture system.
Time frame: Baseline
Knee joint angle
Knee angle during level ground walking measured in degrees measured with a motion capture system.
Time frame: 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.
Time frame: Immediately post 6-minute walk test
Hip joint angle
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Time frame: Baseline
Hip joint moment
Hip moment during level ground walking measured in newton-meters measured with a motion capture system.
Time frame: Baseline
Hip joint angle
Hip angle during level ground walking measured in degrees measured with a motion capture system.
Time frame: 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.
Time frame: Immediately post 6-minute walk test
Ground reaction forces
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Time frame: Baseline
Ground reaction forces
Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Time frame: Immediately post 6-minute walk test
Center of pressure - right leg
Whole body center of pressure displacement
Time frame: Baseline
Center of pressure - left leg
Whole body center of pressure displacement
Time frame: Baseline
Center of pressure - bilateral
Whole body center of pressure displacement
Time frame: Baseline
Timed-up and go
Time (seconds) for participant to stand up from chair, walk 3 meters, and return
Time frame: Baseline
Sit-to-stand
Time (seconds) for participant to stand up from chair and sit back down (5 repetitions)
Time frame: Baseline
Time Up and Down Stairs
Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs
Time frame: 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
Time frame: 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
Time frame: Baseline
Subcutaneous adipose tissue
Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Baseline
Height
Height collected using a stadiometer
Time frame: Baseline
Weight
Weight collected using a stadiometer
Time frame: Baseline
Plan to share: Yes — Deidentified study data and analytic code to be made available using Open Science Framework
Supporting information: Sap, Analytic code
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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.
University of Southern Mississippi