Clinical trial NCT04298944: Association of Mood With Risk for Atherosclerosis
Official title: AuRA Study: Association of Mood With Risk for Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Disorders
Hypertension
Overweight and Obesity
Vascular Stiffness
Sleep
Elevated Blood Pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-03-06
Enrollment: 37
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults up to 22 years of age who belong to either of the following groups:

1. overweight/obese and no history of mood disorders
2. overweight/obese with a mood disorder
3. not overweight/obese with a mood disorder

Brief summary: The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children.

The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.

Detailed description: This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.

Eligibility criteria: Inclusion Criteria:

* Children Ages ≤ 22 years old
* Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.

Exclusion Criteria:

* Not able to speak English
* Unable to lie supine
* Significant Arrhythmia
* If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).

Primary outcomes:
measure: Arterial stiffness as assessed by Pulse wave velocity
timeFrame: 1 day
measure: Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)
timeFrame: 1 day
measure: Arterial stiffness as assessed by Augmentation Index
timeFrame: 1 day
measure: Endothelial function as assessed by Laser Doppler flow perfusion
timeFrame: 1 day
measure: Mean Blood pressure (mmHg)
timeFrame: 1 day
Secondary outcomes:
measure: Pediatric Adverse Childhood Events (ACEs) score
timeFrame: 1 day
measure: Children's Emotion Management Scale (CEMS) score
timeFrame: 1 day
measure: Behavior Assessment for Children (BASC) score
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine Division of Pediatric Nephrology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy M Brady, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References: