Skip to content

Improving the Early Detection of Cardiometabolic Disease Risk

A Multi-Modal Approach to Improving the Early Detection of Cardiometabolic Disease Risk

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05885672
Enrollment
200
Registered
2023-06-02
Start date
2023-09-11
Completion date
2024-07-31
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Brief 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. 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

Interventions

BEHAVIORALOnline psychoeducational lifestyle intervention

A webpage-baed intervention focused on lifestyle interventions that aim to reduce metabolic syndrome severity.

Sponsors

University of Mississippi Medical Center
CollaboratorOTHER
University of Southern Mississippi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

\- adults between the ages of 18-39 years of age

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Treatment Seeking BehaviorBaselineWhether 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.
Motivation and Attitudes Towards HealthBaselineMotivation 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 ChangeBaselineReadiness 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).
Cardiac Baroreflex SensitivityBaselineMeasure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography
Blood PressureBaselineResting systolic and diastolic blood pressure
Waist CircumferenceBaselineCircumference of the waist measured by tape measure at the level of the iliac crest
Fasting blood glucoseBaselineBlood glucose collected from capillary blood
Blood lipidsBaselineTriglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood
Metabolic syndrome severity scoreBaselineA 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.
InsulinBaselineInsulin collected from intravenous blood
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)BaselineEquation that estimates insulin resistance from glucose and insulin measurements
Tumor necrosis factor-alphaBaselineCommon biomarker of systemic inflammation collected from intravenous blood
Body fat percentageBaselineThe percentage of body fat estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Fat massBaselineThe weight of fat mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Fat-free massBaselineThe weight of fat-free mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy
Body circumferencesBaselineCentral (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging
Heart Rate VariabilityBaselineIndex of cardiac autonomic control collected via one-lead electrocardiogram
Flow-mediated changes in vascular diameterBaselineChanges in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Flow-mediated changes in blood flowBaselineChanges in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound
Flow-mediated changes in blood pressureBaselineChanges in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography
Flow-mediated changes in vascular conductanceBaselineChanges in vascular conductance during 5 minutes of post-occlusive reactive hyperemia calculated as flow per unit of blood pressure
Flow-mediated changes in vascular resistanceBaselineChanges 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 oxygenationBaselineChanges 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 DiameterBaselineChanges in vascular diameter during passive limb movement collected via duplex Doppler ultrasound
Passive Limb Movement Mediated Changes in Blood FlowBaselineChanges in blood flow during passive limb movement collected via duplex Doppler ultrasound
Passive Limb Movement Mediated Changes in Blood PressureBaselineChanges in blood pressure during passive limb movement collected via finger photoplethysmography
Passive Limb Movement Mediated Changes in Vascular ConductanceBaselineChanges in vascular conductance during passive limb movement calculated as flow per unit of pressure
Passive Limb Movement Mediated Changes in Vascular ResistanceBaselineChanges in vascular resistance during passive limb movement calculated as the pressure per unit of flow
Passive Limb Movement Mediated Changes in Skeletal Muscle OxygenationBaselineChanges in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy
Carotid-Femoral Pulse Wave VelocityBaselineIndex of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis
Cold Pressor Test Blood Pressure ResponsesBaselineChanges in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography
Cold Pressor Test Heart Rate ResponsesBaselineChanges in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram
Cold Pressor Test Vascular Conductance ResponsesBaselineChanges in vascular conductance during three minutes of cold-pressor activation calculated as flow per unit of pressure
Cold Pressor Test Vascular Resistance ResponsesBaselineChanges in vascular resistance during three minutes of cold-pressor activation calculated as pressure per unit of flow
Cold Pressor Test stroke volume ResponsesBaselineChanges in stroke volume during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Cold Pressor Test Cardiac Output ResponsesBaselineChanges in cardiac output during three minutes of cold-pressor activation collected via finger photoplethysmography or duplex Doppler ultrasound
Metaboreflex Blood Pressure ResponsesBaselineChanges 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 ResponsesBaselineChanges 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 ResponsesBaselineChanges 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 ResponsesBaselineChanges 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 ResponsesBaselineChanges 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 ResponsesBaselineChanges 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 ResponsesBaselineChanges in limb blood flow during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise Collected via finger photoplethysmography
Functional Sympatholysis Vascular Conductance ResponsesBaselineChanges 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 ResponsesBaselineChanges 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 ResponsesBaselineChanges in blood pressure during three minutes of cold-pressor activation with superimposed rhythmic handgrip exercise collected via finger photoplethysmography
Gait velocityBaselineSelf-selected walking velocity over level ground measured with a timing gate system.
Stride LengthBaselineLength of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Stride WidthBaselineWidth of stride, measured as the lateral distance between feet during walking measured with a motion capture system.
Gait CadenceBaselineSteps taken per minute measured with a motion capture system.
Ankle joint angleBaselineAnkle angle during level ground walking measured in degrees measured with a motion capture system.
Ankle joint momentBaselineAnkle moment during level ground walking measured in newton-meters measured with a motion capture system.
Knee joint angleBaselineKnee angle during level ground walking measured in degrees measured with a motion capture system.
Knee joint momentBaselineKnee moment during level ground walking measured in newton-meters measured with a motion capture system.
Hip joint angleBaselineHip angle during level ground walking measured in degrees measured with a motion capture system.
Hip joint momentBaselineHip moment during level ground walking measured in newton-meters measured with a motion capture system.
Ground reaction forcesBaselineThree-dimensional ground reaction forces during level ground walking measured with a motion capture system.
Center of pressure - right legBaselineWhole body center of pressure displacement
Center of pressure - left legBaselineWhole body center of pressure displacement
Center of pressure - bilateralBaselineWhole body center of pressure displacement
Timed-up and goBaselineTime (seconds) for participant to stand up from chair, walk 3 meters, and return
Sit-to-standBaselineTime (seconds) for participant to stand up from chair and sit back down (5 repetitions)
Time Up and Down StairsBaselineTime (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs
Isometric strengthBaselineIsometric muscle strength of hip flexors and extensors, knee flexors and extensors, and ankle dorsi- and plantar flexors of the right leg
Visceral adipose tissueBaselineAbsolute fat-mass around the visceral organs in kilograms measured using dual-energy x-ray absorptiometry and near-infrared reactance spectroscopy
Subcutaneous adipose tissueBaselineAbsolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry

Secondary

MeasureTime frameDescription
WeightBaselineWeight collected using a stadiometer
HeightBaselineHeight collected using a stadiometer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026