Clinical trial NCT05885672: Improving the Early Detection of Cardiometabolic Disease Risk
Official title: A Multi-Modal Approach to Improving the Early Detection of Cardiometabolic Disease Risk
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Metabolic Syndrome
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2023-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young adults between the ages of 18 and 39 with or without 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


Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline
measure: Waist Circumference
timeFrame: Baseline
measure: Fasting blood glucose
timeFrame: Baseline
measure: Blood lipids
timeFrame: Baseline
measure: Metabolic syndrome severity score
timeFrame: Baseline
measure: Insulin
timeFrame: Baseline
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Baseline
measure: Tumor necrosis factor-alpha
timeFrame: Baseline
measure: Body fat percentage
timeFrame: Baseline
measure: Fat mass
timeFrame: Baseline
measure: Fat-free mass
timeFrame: Baseline
measure: Body circumferences
timeFrame: Baseline
measure: Heart Rate Variability
timeFrame: Baseline
measure: Cardiac Baroreflex Sensitivity
timeFrame: Baseline
measure: Flow-mediated changes in vascular diameter
timeFrame: Baseline
measure: Flow-mediated changes in blood flow
timeFrame: Baseline
measure: Flow-mediated changes in blood pressure
timeFrame: Baseline
measure: Flow-mediated changes in vascular conductance
timeFrame: Baseline
measure: Flow-mediated changes in vascular resistance
timeFrame: Baseline
measure: Flow-mediated changes in skeletal muscle oxygenation
timeFrame: Baseline
measure: Passive Limb Movement Mediated Changes in Vascular Diameter
timeFrame: Baseline
measure: Passive Limb Movement Mediated Changes in Blood Flow
timeFrame: Baseline
measure: Passive Limb Movement Mediated Changes in Blood Pressure
timeFrame: Baseline
measure: Passive Limb Movement Mediated Changes in Vascular Conductance
timeFrame: Baseline
measure: Passive Limb Movement Mediated Changes in Vascular Resistance
timeFrame: Baseline
measure: Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation
timeFrame: Baseline
measure: Carotid-Femoral Pulse Wave Velocity
timeFrame: Baseline
measure: Cold Pressor Test Blood Pressure Responses
timeFrame: Baseline
measure: Cold Pressor Test Heart Rate Responses
timeFrame: Baseline
measure: Cold Pressor Test Vascular Conductance Responses
timeFrame: Baseline
measure: Cold Pressor Test Vascular Resistance Responses
timeFrame: Baseline
measure: Cold Pressor Test stroke volume Responses
timeFrame: Baseline
measure: Cold Pressor Test Cardiac Output Responses
timeFrame: Baseline
measure: Metaboreflex Blood Pressure Responses
timeFrame: Baseline
measure: Metaboreflex Heart Rate Responses
timeFrame: Baseline
measure: Metaboreflex Vascular Conductance Responses
timeFrame: Baseline
measure: Metaboreflex Vascular Resistance Responses
timeFrame: Baseline
measure: Metaboreflex Stroke Volume Responses
timeFrame: Baseline
measure: Metaboreflex Cardiac Output Responses
timeFrame: Baseline
measure: Functional Sympatholysis Blood Flow Responses
timeFrame: Baseline
measure: Functional Sympatholysis Vascular Conductance Responses
timeFrame: Baseline
measure: Functional Sympatholysis Vascular Resistance Responses
timeFrame: Baseline
measure: Functional Sympatholysis Blood Pressure Responses
timeFrame: Baseline
measure: Gait velocity
timeFrame: Baseline
measure: Gait velocity
timeFrame: Immediately post 6-minute walk test
measure: Stride Length
timeFrame: Baseline
measure: Stride Length
timeFrame: Immediately post 6-minute walk test
measure: Stride Width
timeFrame: Baseline
measure: Stride Width
timeFrame: Immediately post 6-minute walk test
measure: Gait Cadence
timeFrame: Baseline
measure: Gait Cadence
timeFrame: Immediately post 6-minute walk test
measure: Ankle joint angle
timeFrame: Baseline
measure: Ankle joint moment
timeFrame: Baseline
measure: Ankle joint angle
timeFrame: Immediately post 6-minute walk test
measure: Ankle joint moment
timeFrame: Immediately post 6-minute walk test
measure: Knee joint angle
timeFrame: Baseline
measure: Knee joint moment
timeFrame: Baseline
measure: Knee joint angle
timeFrame: Immediately post 6-minute walk test
measure: Knee joint moment
timeFrame: Immediately post 6-minute walk test
measure: Hip joint angle
timeFrame: Baseline
measure: Hip joint moment
timeFrame: Baseline
measure: Hip joint angle
timeFrame: Immediately post 6-minute walk test
measure: Hip joint moment
timeFrame: Immediately post 6-minute walk test
measure: Ground reaction forces
timeFrame: Baseline
measure: Ground reaction forces
timeFrame: Immediately post 6-minute walk test
measure: Center of pressure - right leg
timeFrame: Baseline
measure: Center of pressure - left leg
timeFrame: Baseline
measure: Center of pressure - bilateral
timeFrame: Baseline
measure: Timed-up and go
timeFrame: Baseline
measure: Sit-to-stand
timeFrame: Baseline
measure: Time Up and Down Stairs
timeFrame: Baseline
measure: Isometric strength
timeFrame: Baseline
measure: Visceral adipose tissue
timeFrame: Baseline
measure: Subcutaneous adipose tissue
timeFrame: Baseline
measure: Motivation and Attitudes Towards Health
timeFrame: Baseline
measure: Readiness for Behavior Change
timeFrame: Baseline
measure: Treatment Seeking Behavior
timeFrame: Baseline
Secondary outcomes:
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: University of Southern Mississippi - School of Kinesiology and Nutrition
state: Mississippi
Study officials:
affiliation: University of Southern Mississippi
name: Austin J Graybeal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Mississippi
name: Jon Stavres, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Mississippi
name: Tanner Thorsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Mississippi
name: Megan Renna, PhD
role: PRINCIPAL_INVESTIGATOR
References: