Improving the Early Detection of Cardiometabolic Disease Risk

NCT05885672 | Enrolling By Invitation

• 1 other identifier: 23-0446
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (77)

• Blood Pressure

  Resting systolic and diastolic blood pressure

  Baseline

• Waist Circumference

  Circumference of the waist measured by tape measure at the level of the iliac crest

  Baseline

• Fasting blood glucose

  Blood glucose collected from capillary blood

  Baseline

• Blood lipids

  Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood

  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.

  Baseline

• Insulin

  Insulin collected from intravenous blood

  Baseline

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Equation that estimates insulin resistance from glucose and insulin measurements

  Baseline

• Tumor necrosis factor-alpha

  Common biomarker of systemic inflammation collected from intravenous blood

  Baseline

• Body fat percentage

  The percentage of body fat estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy

  Baseline

• Fat mass

  The weight of fat mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy

  Baseline

• Fat-free mass

  The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging and near-infrared reactance spectroscopy

  Baseline

• Body circumferences

  Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging

  Baseline

• Heart Rate Variability

  Index of cardiac autonomic control collected via one-lead electrocardiogram

  Baseline

• Cardiac Baroreflex Sensitivity

  Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography

  Baseline

• Flow-mediated changes in vascular diameter

  Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound

  Baseline

• Flow-mediated changes in blood flow

  Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound

  Baseline

• Flow-mediated changes in blood pressure

  Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography

  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

  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

  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

  Baseline

• Passive Limb Movement Mediated Changes in Vascular Diameter

  Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound

  Baseline

• Passive Limb Movement Mediated Changes in Blood Flow

  Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound

  Baseline

• Passive Limb Movement Mediated Changes in Blood Pressure

  Changes in blood pressure during passive limb movement collected via finger photoplethysmography

  Baseline

• Passive Limb Movement Mediated Changes in Vascular Conductance

  Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure

  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

  Baseline

• Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation

  Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy

  Baseline

• Carotid-Femoral Pulse Wave Velocity

  Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis

  Baseline

• Cold Pressor Test Blood Pressure Responses

  Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography

  Baseline

• Cold Pressor Test Heart Rate Responses

  Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Baseline

• Gait velocity

  Self-selected walking velocity over level ground measured with a timing gate system.

  Baseline

• Gait velocity

  Self-selected walking velocity over level ground measured with a timing gate system.

  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.

  Baseline

• Stride Length

  Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.

  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.

  Baseline

• Stride Width

  Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.

  Immediately post 6-minute walk test

• Gait Cadence

  Steps taken per minute measured with a motion capture system.

  Baseline

• Gait Cadence

  Steps taken per minute measured with a motion capture system.

  Immediately post 6-minute walk test

• Ankle joint angle

  Ankle angle during level ground walking measured in degrees measured with a motion capture system.

  Baseline

• Ankle joint moment

  Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.

  Baseline

• Ankle joint angle

  Ankle angle during level ground walking measured in degrees measured with a motion capture system.

  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.

  Immediately post 6-minute walk test

• Knee joint angle

  Knee angle during level ground walking measured in degrees measured with a motion capture system.

  Baseline

• Knee joint moment

  Knee moment during level ground walking measured in newton-meters measured with a motion capture system.

  Baseline

• Knee joint angle

  Knee angle during level ground walking measured in degrees measured with a motion capture system.

  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.

  Immediately post 6-minute walk test

• Hip joint angle

  Hip angle during level ground walking measured in degrees measured with a motion capture system.

  Baseline

• Hip joint moment

  Hip moment during level ground walking measured in newton-meters measured with a motion capture system.

  Baseline

• Hip joint angle

  Hip angle during level ground walking measured in degrees measured with a motion capture system.

  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.

  Immediately post 6-minute walk test

• Ground reaction forces

  Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.

  Baseline

• Ground reaction forces

  Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.

  Immediately post 6-minute walk test

• Center of pressure - right leg

  Whole body center of pressure displacement

  Baseline

• Center of pressure - left leg

  Whole body center of pressure displacement

  Baseline

• Center of pressure - bilateral

  Whole body center of pressure displacement

  Baseline

• Timed-up and go

  Time (seconds) for participant to stand up from chair, walk 3 meters, and return

  Baseline

• Sit-to-stand

  Time (seconds) for participant to stand up from chair and sit back down (5 repetitions)

  Baseline

• Time Up and Down Stairs

  Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs

  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

  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

  Baseline

• Subcutaneous adipose tissue

  Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry

  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

  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).

  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.

  Baseline

Secondary Outcomes (2)

• Height

  Baseline

• Weight

  Baseline

Study Arms (1)

Young Adults

Adults between the ages of 18 and 39 years

Behavioral: Online psychoeducational lifestyle intervention

Interventions

Online psychoeducational lifestyle intervention BEHAVIORAL

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

Young Adults

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Young adults between the ages of 18 and 39 with or without metabolic syndrome

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Mississippi: lead
• University of Mississippi Medical Center: collaborator

Study Sites (1)

University of Southern Mississippi - School of Kinesiology and Nutrition

Hattiesburg, Mississippi, 39406, United States

Location

Related Publications (1)

• 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.

  PMID: 38902464 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Capillary and intravenous blood collection for the analysis of: * Glucose * Insulin * Blood Lipids * Inflammatory biomarkers (tumor necrosis factor-a)

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Austin J Graybeal, PhD

  University of Southern Mississippi

  PRINCIPAL INVESTIGATOR

• Jon Stavres, PhD

  University of Southern Mississippi

  PRINCIPAL INVESTIGATOR

• Tanner Thorsen, PhD

  University of Southern Mississippi

  PRINCIPAL INVESTIGATOR

• Megan Renna, PhD

  University of Southern Mississippi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 2, 2023
• Study Start: September 11, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Upon publication of the primary results and will be kept available for 18 months

Locations

US (1)