Trauma and Cardiometabolic Health in an American Indian Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Changes in systolic blood pressure activity from baseline to task
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •Identifying as American Indian
- •Living on or near Blackfeet reservation
排除标准
- •Uncontrolled hypertension
结局指标
主要结局
Changes in systolic blood pressure activity from baseline to task
时间窗: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
The mean systolic blood pressure (mmHg) will be subtracted from the mean of the task period.
Changes in diastolic blood pressure activity from baseline to task
时间窗: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
The mean diastolic blood pressure (mmHg) will be subtracted from the mean of the task period.
Changes in heart rate activity from baseline to task
时间窗: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
The mean heart rate (bpm) will be subtracted from the mean of the task period.
Change in cortisol from baseline to task
时间窗: Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset)
Salivary samples will be taken to measure cortisol (nmol/L) the mean from the peak stress period will be subtracted from the baseline
Changes in IL-6 from baseline to task
时间窗: Baseline will be subtracted from the level 30 minutes after task onset.
IL-6 (pg/mL) measured at baseline will be subtracted from the IL-6 measured post task.
Pulse wave velocity
时间窗: 5 minutes
Pulse wave velocity in m/s will be assessed by dual impedance cardiography as a non-invasive indicator of arterial stiffness. This measure will be derived from the 5 minute baseline period.
Resting systolic blood pressure
时间窗: 10 minutes
Resting systolic blood pressure (mmHg)
Resting diastolic blood pressure
时间窗: 10 minutes
Resting diastolic blood pressure (mmHg)
Inflammatory and anti-inflammatory cytokines
时间窗: 5 minutes
Circulating levels of C-reactive protein, interleukin-6, tumor necrosis factor-a, monocyte chemoattractant protein-1, interleukin-1b, interleukin-10, and adiponectin will be assessed via a blood draw. A composite score will be created.
Hemoglobin A1c
时间窗: 5 minutes
Hemoglobin A1c (nmol/L) will be assessed via blood draw
Glucose
时间窗: 5 minutes
Glucose (nmol/L) will be assessed via blood draw
Insulin
时间窗: 5 minutes
Insulin (mL) will be assessed via blood draw
Cholesterol
时间窗: 5 minutes
Total cholesterol (mg) will be assessed via blood draw
Low-density lipoprotein
时间窗: 5 minutes
Low-density lipoprotein (mg/dL) will be assessed via blood draw
High-density lipoprotein
时间窗: 5 minutes
high-density lipoprotein (mg/dL) will be assessed via blood draw
Triglycerides
时间窗: 5 minutes
Triglycerides (mmol/L) will be assessed via blood draw
Waist circumference
时间窗: 2 minutes
Waist circumference
Hip circumference
时间窗: 2 minutes
Hip circumference
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)
时间窗: 10 minutes
Hospital Anxiety Depression Questionnaire (depression subscale)
Depressive symptomology (PHQ-9)
时间窗: 10 minutes
PHQ-9
Anxiety symptomtology
时间窗: 5 minutes
Hospital Anxiety Depression Questionnaire (Anxiety subscale)
Alcohol use
时间窗: 10 minutes
Alcohol use will be assessed using the Alcohol Use Identification Test
Substance use
时间窗: 5 minutes
A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried
次要结局
未报告次要终点