Trauma and Cardiometabolic Health in an American Indian Community

Not Applicable

Recruiting

• Conditions: Psychological Stress; Cardiometabolic Conditions; Mental Health

• Registration Number: NCT06878885
• Lead Sponsor: Montana State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-05-10
• Study First Submitted: 2025-01-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Glucose	5 minutes	Glucose (nmol/L) will be assessed via blood draw
Changes in systolic blood pressure activity from baseline to task	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	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	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	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	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	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	10 minutes	Resting systolic blood pressure (mmHg)
Resting diastolic blood pressure	10 minutes	Resting diastolic blood pressure (mmHg)
Inflammatory and anti-inflammatory cytokines	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	5 minutes	Hemoglobin A1c (nmol/L) will be assessed via blood draw
Insulin	5 minutes	Insulin (mL) will be assessed via blood draw
Cholesterol	5 minutes	Total cholesterol (mg) will be assessed via blood draw
Low-density lipoprotein	5 minutes	Low-density lipoprotein (mg/dL) will be assessed via blood draw
High-density lipoprotein	5 minutes	high-density lipoprotein (mg/dL) will be assessed via blood draw
Triglycerides	5 minutes	Triglycerides (mmol/L) will be assessed via blood draw
Waist circumference	2 minutes	Waist circumference
Hip circumference	2 minutes	Hip circumference
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)	10 minutes	Hospital Anxiety Depression Questionnaire (depression subscale)
Depressive symptomology (PHQ-9)	10 minutes	PHQ-9
Anxiety symptomtology	5 minutes	Hospital Anxiety Depression Questionnaire (Anxiety subscale)
Alcohol use	10 minutes	Alcohol use will be assessed using the Alcohol Use Identification Test
Substance use	5 minutes	A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried

Trial Locations

Locations (1)

Blackfeet Community College; 🇺🇸 Browning, Montana, United States