Improving the Early Detection of Cardiometabolic Disease Risk

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05885672
• Other study ID #: 23-0446
• Status: Enrolling by invitation
• Start date: September 11, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Southern Mississippi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

Behavioral:
• Online psychoeducational lifestyle intervention
A webpage-baed intervention focused on lifestyle interventions that aim to reduce metabolic syndrome severity.

Locations

Country	Name	City	State
United States	University of Southern Mississippi - School of Kinesiology and Nutrition	Hattiesburg	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Mississippi	University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Resting systolic and diastolic blood pressure	Baseline
Primary	Waist Circumference	Circumference of the waist measured by tape measure at the level of the iliac crest	Baseline
Primary	Fasting blood glucose	Blood glucose collected from capillary blood	Baseline
Primary	Blood lipids	Triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol collected from capillary blood	Baseline
Primary	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
Primary	Insulin	Insulin collected from intravenous blood	Baseline
Primary	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Equation that estimates insulin resistance from glucose and insulin measurements	Baseline
Primary	Tumor necrosis factor-alpha	Common biomarker of systemic inflammation collected from intravenous blood	Baseline
Primary	Body fat percentage	The percentage of body fat estimated using smartphone-based digital imaging	Baseline
Primary	Fat mass	The weight of fat mass in kilograms estimated using smartphone-based digital imaging	Baseline
Primary	Fat-free mass	The weight of fat-free mass in kilograms estimated using smartphone-based digital imaging	Baseline
Primary	Body circumferences	Central (trunk) and segmental (arms and legs) circumference estimated using smartphone-based digital imaging	Baseline
Primary	Heart Rate Variability	Index of cardiac autonomic control collected via one-lead electrocardiogram	Baseline
Primary	Cardiac Baroreflex Sensitivity	Measure of parasympathetic and sympathetic regulation collected via one-lead electrocardiogram and finger photoplethysmography	Baseline
Primary	Flow-mediated changes in vascular diameter	Changes in vascular diameter during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound	Baseline
Primary	Flow-mediated changes in blood flow	Changes in blood flow during 5 minutes of post-occlusive reactive hyperemia collected via duplex Doppler ultrasound	Baseline
Primary	Flow-mediated changes in blood pressure	Changes in blood pressure during 5 minutes of post-occlusive reactive hyperemia collected via finger photoplethysmography	Baseline
Primary	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
Primary	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
Primary	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
Primary	Passive Limb Movement Mediated Changes in Vascular Diameter	Changes in vascular diameter during passive limb movement collected via duplex Doppler ultrasound	Baseline
Primary	Passive Limb Movement Mediated Changes in Blood Flow	Changes in blood flow during passive limb movement collected via duplex Doppler ultrasound	Baseline
Primary	Passive Limb Movement Mediated Changes in Blood Pressure	Changes in blood pressure during passive limb movement collected via finger photoplethysmography	Baseline
Primary	Passive Limb Movement Mediated Changes in Vascular Conductance	Changes in vascular conductance during passive limb movement calculated as flow per unit of pressure	Baseline
Primary	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
Primary	Passive Limb Movement Mediated Changes in Skeletal Muscle Oxygenation	Changes in skeletal muscle oxygenation during passive limb movement collected via near-infrared spectroscopy	Baseline
Primary	Carotid-Femoral Pulse Wave Velocity	Index of arterial stiffness collected during rest collected via applanation tonometry and auscultation based wave analysis	Baseline
Primary	Cold Pressor Test Blood Pressure Responses	Changes in blood pressure during three minutes of cold-pressor activation collected via finger photoplethysmography	Baseline
Primary	Cold Pressor Test Heart Rate Responses	Changes in heart rate during three minutes of cold-pressor activation collected via one-lead electrocardiogram	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Gait velocity	Self-selected walking velocity over level ground measured with a timing gate system.	Baseline
Primary	Gait velocity	Self-selected walking velocity over level ground measured with a timing gate system.	Immediately post 6-minute walk test
Primary	Stride Length	Length of stride, measured as the lateral distance between feet during walking measured with a motion capture system.	Baseline
Primary	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
Primary	Stride Width	Width of stride, measured as the lateral distance between feet during walking measured with a motion capture system.	Baseline
Primary	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
Primary	Gait Cadence	Steps taken per minute measured with a motion capture system.	Baseline
Primary	Gait Cadence	Steps taken per minute measured with a motion capture system.	Immediately post 6-minute walk test
Primary	Ankle joint angle	Ankle angle during level ground walking measured in degrees measured with a motion capture system.	Baseline
Primary	Ankle joint moment	Ankle moment during level ground walking measured in newton-meters measured with a motion capture system.	Baseline
Primary	Ankle joint angle	Ankle angle during level ground walking measured in degrees measured with a motion capture system.	Immediately post 6-minute walk test
Primary	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
Primary	Knee joint angle	Knee angle during level ground walking measured in degrees measured with a motion capture system.	Baseline
Primary	Knee joint moment	Knee moment during level ground walking measured in newton-meters measured with a motion capture system.	Baseline
Primary	Knee joint angle	Knee angle during level ground walking measured in degrees measured with a motion capture system.	Immediately post 6-minute walk test
Primary	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
Primary	Hip joint angle	Hip angle during level ground walking measured in degrees measured with a motion capture system.	Baseline
Primary	Hip joint moment	Hip moment during level ground walking measured in newton-meters measured with a motion capture system.	Baseline
Primary	Hip joint angle	Hip angle during level ground walking measured in degrees measured with a motion capture system.	Immediately post 6-minute walk test
Primary	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
Primary	Ground reaction forces	Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.	Baseline
Primary	Ground reaction forces	Three-dimensional ground reaction forces during level ground walking measured with a motion capture system.	Immediately post 6-minute walk test
Primary	Center of pressure - right leg	Whole body center of pressure displacement	Baseline
Primary	Center of pressure - left leg	Whole body center of pressure displacement	Baseline
Primary	Center of pressure - bilateral	Whole body center of pressure displacement	Baseline
Primary	Timed-up and go	Time (seconds) for participant to stand up from chair, walk 3 meters, and return	Baseline
Primary	Sit-to-stand	Time (seconds) for participant to stand up from chair and sit back down (5 repetitions)	Baseline
Primary	Time Up and Down Stairs	Time (seconds) for participant to stand ascend and descend a single flight (10 steps) of stairs	Baseline
Primary	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
Primary	Visceral adipose tissue	Absolute fat-mass around the visceral organs in kilograms measured using dual-energy x-ray absorptiometry.	Baseline
Primary	Subcutaneous adipose tissue	Absolute fat-mass under the cutaneous layer of the skin in kilograms measured using dual-energy x-ray absorptiometry	Baseline
Primary	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
Primary	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
Primary	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	Height	Height collected using a stadiometer	Baseline
Secondary	Weight	Weight collected using a stadiometer	Baseline