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Trauma and Cardiometabolic Health in an American Indian Community

Trauma and Cardiometabolic Health in an American Indian Community

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06878885
Acronym
IHPIPO'TO'TSP
Enrollment
400
Registered
2025-03-17
Start date
2024-05-10
Completion date
2027-06-30
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Conditions, Mental Health, Psychological Stress

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.

Interventions

BEHAVIORALAcute 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Baylor University
CollaboratorOTHER
Blackfeet Community College
CollaboratorOTHER
Montana State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

The study is designed to examine cardiovascular, neuroendocrine, and inflammatory responses to a brief (4 minutes) mental arithmetic task (i.e., a psychological challenge) in the laboratory. Cardiovascular activity will be measured during a resting baseline period (10 minutes) and during the task (4 minutes). Participants will provide salivary samples before the task and after the task (\ 20-90 minutes) which will be used to assess neuroendocrine (i.e., cortisol) and inflammatory (i.e., IL-6). Cardiovascular, neuroendocrine, and inflammatory responses will be examined in relation to other study outcomes.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Uncontrolled hypertension

Design outcomes

Primary

MeasureTime frameDescription
Changes in systolic blood pressure activity from baseline to task10 minute resting baseline mean will be subtracted from the 4 minute task period for each valueThe mean systolic blood pressure (mmHg) will be subtracted from the mean of the task period.
Changes in diastolic blood pressure activity from baseline to task10 minute resting baseline mean will be subtracted from the 4 minute task period for each valueThe mean diastolic blood pressure (mmHg) will be subtracted from the mean of the task period.
Changes in heart rate activity from baseline to task10 minute resting baseline mean will be subtracted from the 4 minute task period for each valueThe mean heart rate (bpm) will be subtracted from the mean of the task period.
Change in cortisol from baseline to taskBaseline 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 taskBaseline 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 velocity5 minutesPulse 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 pressure10 minutesResting systolic blood pressure (mmHg)
Resting diastolic blood pressure10 minutesResting diastolic blood pressure (mmHg)
Inflammatory and anti-inflammatory cytokines5 minutesCirculating 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 A1c5 minutesHemoglobin A1c (nmol/L) will be assessed via blood draw
Glucose5 minutesGlucose (nmol/L) will be assessed via blood draw
Insulin5 minutesInsulin (mL) will be assessed via blood draw
Cholesterol5 minutesTotal cholesterol (mg) will be assessed via blood draw
Low-density lipoprotein5 minutesLow-density lipoprotein (mg/dL) will be assessed via blood draw
High-density lipoprotein5 minuteshigh-density lipoprotein (mg/dL) will be assessed via blood draw
Triglycerides5 minutesTriglycerides (mmol/L) will be assessed via blood draw
Waist circumference2 minutesWaist circumference
Hip circumference2 minutesHip circumference
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)10 minutesHospital Anxiety Depression Questionnaire (depression subscale)
Depressive symptomology (PHQ-9)10 minutesPHQ-9
Anxiety symptomtology5 minutesHospital Anxiety Depression Questionnaire (Anxiety subscale)
Alcohol use10 minutesAlcohol use will be assessed using the Alcohol Use Identification Test
Substance use5 minutesA cumulative score of substance use will be reported by indicating the number of recreational drugs ever tried

Countries

United States

Contacts

Primary ContactNeha John-Henderson, PhD
neha.johnhenderson@montana.edu(406) 994-6052
Backup ContactAnnie Ginty, PhD
annie_ginty@baylor.edu(254)710-2236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026