Идёт набор NCT07430839

Exercise and Carotid Artery Function in Metabolic Syndrome

— Наблюдательное Metabolic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: exercise, Diagnostics, Inhaled CO2-mixed air.
Кому может быть актуально: Состояния в реестре: Metabolic Syndrome. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Identifying Sex-specific Carotid Endothelial Dysfunction in Young Adults With Metabolic Syndrome

Обзор

The purpose of this study is to determine 1) if young adults with metabolic syndrome display endothelial dysfunction of the internal carotid artery in a sex-specific fashion and 2) if this endothelial dysfunction can be acutely improved with a single bout of exercise. This will be achieved by testing internal carotid artery function before and after a 30-minute bout of moderate intensity exercise. 48 young adults with and without metabolic syndrome will be enrolled and will be on study for approximately 5.5 hours over 4 study visits.

Подробное описание

The goal of this project is to determine if young MetSyn patients exhibit carotid endothelial dysfunction (ED) in a sex-specific manner and if exercise can acutely restore internal carotid artery (ICA) function.

The investigators will test this by first quantifying ICA endothelial function using an inhaled gas stressor (CO2) to acutely increase ICA shear rate (SR) and measuring the vascular responsiveness to this increased SR. Carotid endothelial function has never been tested in this way in patients with MetSyn before. Then, a 30 min bout of cycling exercise will be performed followed by the same gas stressor test to determine if ICA endothelial function can be acutely improved in MetSyn.

The aims and hypotheses are to:

* Aim 1: Determine if young adults with MetSyn exhibit carotid ED compared to healthy adults. Hypothesis: carotid ED will be present in young adults with MetSyn. * Aim 2: Determine if sex differences exist in carotid endothelial function in MetSyn. Hypothesis: MetSyn will result in greater declines in carotid endothelial function in females. * Aim 3: Determine if exercise yields an acute benefit on carotid endothelial function in young adults with MetSyn. Hypothesis: young adults with MetSyn will receive a greater increase in carotid endothelial function from a single bout of exercise than healthy adults.

Вмешательства

Поведенческое exercise
30 minute bout of cycling
Диагностический тест Diagnostics
* Doppler Ultrasound used to non-invasively assess the diameter and blood flow going into an artery, the ICA in this study. * Indirect calorimeter in tandem with semi-recumbent bike used to assess O2 consumption * heart rate monitor
Другое Inhaled CO2-mixed air
Three gases of different composition are used to ensure that the proper PETCO2 administration desired for this study occurs in tandem with keeping inspired O2 content constant. This is achieved by used a 5% O2, 95% CO2 tank, a 5% O2, 95% N2 tank, and a 100% O2 tank. In tandem, the use of these three tanks allows for precise control of PETCO2 without a change in inspired O2.

Первичные конечные точки

Aim 1: Baseline ICA cSMD measures assessed by MetSyn versus healthy controls [Срок оценки: baseline]
Aim 2: Baseline ICA cSMD measures assessed by MetSyn versus sex [Срок оценки: baseline]
Aim 3: Post-exercise cSMD response by MetSyn versus healthy controls [Срок оценки: measured during exercise and 10 and 60 minutes post-exercise]

Вторичные конечные точки (1)

Aim 3: Duration of Response to Exercise [Срок оценки: measured during exercise and 10 and 60 minutes post-exercise]

Критерии участия

Inclusion Criteria (MetSyn cohort):

Waist circumference greater than 102 cm (males) or 82 cm (females)
Triglycerides over 150 mg/dL
HDL cholesterol less than 40 mg/dL (males) or 50 mg/dL (females)
Blood pressure ≥130/85 mmHg
Fasting plasma glucose over 110 mg/dL

Inclusion Criteria (Healthy cohort):

\- meet age criteria

Критерии исключения

Current smoker, defined as more than 5 cigarettes over past 30 days
Current diagnosis or history of:

peripheral vascular disease
hepatic disease
renal disease
lung disease
gastrointestinal disorders/bleeding
hematologic disease
stroke
myocardial infarction
coronary heart disease
congestive heart failure
heart surgery
sleep apnea
autoimmune diseases
traumatic brain injury, concussion, stroke, or seizures
Asthma
Polycystic ovarian syndrome
Type II diabetes
Currently pregnant or breastfeeding
Current musculoskeletal injury Medication use known to influence cardiovascular function, other than oral contraceptives
Hormonal contraceptive use, such as intrauterine device or hormonal implant use
Participants with ICAs unsuitable for imaging, as assessed during the screening visit via doppler ultrasonography