Trauma and Cardiometabolic Health in an American Indian Community

Обзор

Volunteers for the study are asked to participate in two laboratory sessions. In the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. Participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. In the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. Participants will also complete questionnaires. The study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.

Подробное описание

This cross-sectional study will examine the association between factors of resiliency and trauma with physiological (cardiovascular, neuroendocrine, inflammatory) responses to acute stress and current mental and physical health. Study volunteers will include individuals who identify as American Indian and currently live on and near the Blackfeet Reservation. Study volunteers will be asked to provide information that will be used to measure: correlates of cardiometabolic and mental health, acute psychological stress, arterial stiffness. Results of the study will help increase knowledge of cardiometabolic and mental health in the context of past and ongoing trauma and resiliency.

Вмешательства

• Поведенческое Acute psychological stress task (Paced Auditory Serial Addition Task)
  Volunteers will complete a 4-minute Paced Auditory Serial Addition Task which is a standardized laboratory challenge that is widely used to monitor cardiovascular, neuroendocrine, and inflammatory responses in the laboratory.

Первичные конечные точки

• Changes in systolic blood pressure activity from baseline to task [Срок оценки: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value]
• Changes in diastolic blood pressure activity from baseline to task [Срок оценки: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value]
• Changes in heart rate activity from baseline to task [Срок оценки: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value]
• Change in cortisol from baseline to task [Срок оценки: Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset)]
• Changes in IL-6 from baseline to task [Срок оценки: Baseline will be subtracted from the level 30 minutes after task onset.]
• Pulse wave velocity [Срок оценки: 5 minutes]
• Resting systolic blood pressure [Срок оценки: 10 minutes]
• Resting diastolic blood pressure [Срок оценки: 10 minutes]
• Inflammatory and anti-inflammatory cytokines [Срок оценки: 5 minutes]
• Hemoglobin A1c [Срок оценки: 5 minutes]

Критерии участия

Критерии включения

• 18-40 years
• Identifying as American Indian
• Living on or near Blackfeet reservation

Критерии исключения

• Uncontrolled hypertension

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Blackfeet Community College — Browning

Идентификаторы

NCT: NCT06878885 · 163237 · 5R01HL163237-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗