NCT06878885 · Montana State University
Trauma and Cardiometabolic Health in an American Indian Community
(IHPIPO'TO'TSP)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
Primary outcome measures
Changes in systolic blood pressure activity from baseline to task
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 minutes
Resting systolic blood pressure (mmHg)
Resting diastolic blood pressure
Time frame: 10 minutes
Resting diastolic blood pressure (mmHg)
Inflammatory and anti-inflammatory cytokines
Time frame: 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
Time frame: 5 minutes
Hemoglobin A1c (nmol/L) will be assessed via blood draw
Glucose
Time frame: 5 minutes
Glucose (nmol/L) will be assessed via blood draw
Insulin
Time frame: 5 minutes
Insulin (mL) will be assessed via blood draw
Cholesterol
Time frame: 5 minutes
Total cholesterol (mg) will be assessed via blood draw
Low-density lipoprotein
Time frame: 5 minutes
Low-density lipoprotein (mg/dL) will be assessed via blood draw
High-density lipoprotein
Time frame: 5 minutes
high-density lipoprotein (mg/dL) will be assessed via blood draw
Triglycerides
Time frame: 5 minutes
Triglycerides (mmol/L) will be assessed via blood draw
Waist circumference
Time frame: 2 minutes
Waist circumference
Hip circumference
Time frame: 2 minutes
Hip circumference
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)
Time frame: 10 minutes
Hospital Anxiety Depression Questionnaire (depression subscale)
Depressive symptomology (PHQ-9)
Time frame: 10 minutes
PHQ-9
Anxiety symptomtology
Time frame: 5 minutes
Hospital Anxiety Depression Questionnaire (Anxiety subscale)
Alcohol use
Time frame: 10 minutes
Alcohol use will be assessed using the Alcohol Use Identification Test
Substance use
Time frame: 5 minutes
A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-40 years
- Identifying as American Indian
- Living on or near Blackfeet reservation
Exclusion criteria
- Uncontrolled hypertension
Where
- Browning, Montana
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Baylor University, Blackfeet Community College
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2025 · Source of record for eligibility and locations