Clinical trial NCT06878885: Trauma and Cardiometabolic Health in an American Indian Community
Official title: Trauma and Cardiometabolic Health in an American Indian Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Stress
Cardiometabolic Conditions
Mental Health
Lead sponsor: Montana State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Baylor University
name: Blackfeet Community College
First posted: 2025-03-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Uncontrolled hypertension

Primary outcomes:
measure: Changes in systolic blood pressure activity from baseline to task
timeFrame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
measure: Changes in diastolic blood pressure activity from baseline to task
timeFrame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
measure: Changes in heart rate activity from baseline to task
timeFrame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
measure: Change in cortisol from baseline to task
timeFrame: Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset)
measure: Changes in IL-6 from baseline to task
timeFrame: Baseline will be subtracted from the level 30 minutes after task onset.
measure: Pulse wave velocity
timeFrame: 5 minutes
measure: Resting systolic blood pressure
timeFrame: 10 minutes
measure: Resting diastolic blood pressure
timeFrame: 10 minutes
measure: Inflammatory and anti-inflammatory cytokines
timeFrame: 5 minutes
measure: Hemoglobin A1c
timeFrame: 5 minutes
measure: Glucose
timeFrame: 5 minutes
measure: Insulin
timeFrame: 5 minutes
measure: Cholesterol
timeFrame: 5 minutes
measure: Low-density lipoprotein
timeFrame: 5 minutes
measure: High-density lipoprotein
timeFrame: 5 minutes
measure: Triglycerides
timeFrame: 5 minutes
measure: Waist circumference
timeFrame: 2 minutes
measure: Hip circumference
timeFrame: 2 minutes
measure: Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)
timeFrame: 10 minutes
measure: Depressive symptomology (PHQ-9)
timeFrame: 10 minutes
measure: Anxiety symptomtology
timeFrame: 5 minutes
measure: Alcohol use
timeFrame: 10 minutes
measure: Substance use
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Browning
country: United States
facility: Blackfeet Community College
state: Montana
Study officials:
affiliation: Montana State University
name: Neha John-Henderson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor University
name: Annie Ginty, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blackfeet Community College
name: Betty Henderson-Mathews, MA
role: PRINCIPAL_INVESTIGATOR
References: