Clinical trial NCT02970656: A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect
Official title: A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Miller Foundation
First posted: 2016-11-22
Enrollment: 29
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This feasibility/pilot study has three purposes. First, the investigators will determine the feasibility of collecting saliva to measure stress biomarkers over three days at home in youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet program for youth with type 1 diabetes to determine whether changes in stress biomarkers associate with self-reported perceived stress and HbA1c. Third, the investigators will examine the gene-environment interaction of the top 14 targeted candidate genes and epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose levels over time.

Detailed description: Intensive management of type 1 diabetes (T1D) among youth as recommended by the American Diabetes Association requires a complex set of self-management activities that create high levels of perceived stress in youth and families. In individuals exposed to chronic stress, such as that of a chronic condition, the body responds with physiological and hormonal responses to adapt. These responses can be harmful (e.g., higher glucose levels, higher HbA1c). Such harmful effects may be ameliorated by programs that reduce psychosocial stress.

The investigators have found an Internet-delivered coping skills training program combined with a diabetes education program significantly improved HbA1c and QOL for youth with T1D. Self-reported perceived stress mediated these outcomes. There has been little to no examination, however, of whether a reduction in self-reported perceived stress is associated with a reduction in biochemical markers of stress which could explain the positive impact on HbA1c. It is critically important to understand the physiologic as well as the psychosocial mechanisms associated with such interventions in order to improve glycemic control in youth with this chronic autoimmune condition. If such interventions affect biomarkers of stress, it would be important to strengthen the stress reduction activities embedded in such interventions, such as meditation, to further improve metabolic control. Thus, aims of this pilot/feasibility study are to:

1. Determine the feasibility and reliability of collection of saliva for the measurement of three stress biomarkers at awakening and 30-45 minutes later over 3 days at home in 20 youth (age 11-14 years). These biomarkers include cortisol to assess hypothalamic-pituitary-adrenal axis functioning; alpha-amylase (s-AA) to assess the sympathetic-adrenal-medullary system, and salivary immunoglobulin A (s-IgA) to assess stress-related immune changes. This aim will allow the investigators to determine the feasibility of recruiting youth to provide such data in a larger trial by assessing the percent of youth who agree to participate and adhere to the salivary collection protocol, using actigraphy to document awakening time and Medication Event Monitoring System (MEMS) caps monitoring to determine time of salivary collection. Patterns and variability of stress biomarker levels over 3 days will be used to assess intra-individual variability and relationships with self-reported daily stressors and self-reported perceived stress.
2. Conduct a pilot study of Teens.Connect, a combination of the investigators' previous TEENCOPE™ and Managing Diabetes programs with 40 youth to determine whether alterations in stress biomarkers are associated with self-reported perceived stress and HbA1c.
3. Assess epigenetic components of these responses by examining the gene-environment interaction of the top 14 targeted candidate genes and epigenome wide effects of teens' stress biomarkers and their influence on HbA1c levels over time. Candidate genes will be measured at baseline and DNA methylation patterns will be measured at baseline and then again at 6 months follow-up using the Oragene saliva collection kits.

Eligibility criteria: Inclusion Criteria:

* diagnosed with T1D for at least 6 months;
* age 11 to 14 years
* naïve to TEENCOPE and/or Managing Diabetes
* assent and parent/guardian consent to participate in the study

Exclusion Criteria:

* medical condition that impacts cortisol functioning
* takes medications that impact cortisol, except diabetes medications
* sleeps less than 6 hours per night
* smokes
* takes oral contraceptives

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: baseline
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: 6 months
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: baseline
measure: Perceived Stress Scale
timeFrame: 6 months
measure: Adolescent Stress Questionnaire (ASQ)
timeFrame: baseline
measure: Adolescent Stress Questionnaire (ASQ)
timeFrame: 6 months
measure: Responses to Stress Questionnaire for Diabetes (RSQ)
timeFrame: baseline
measure: Responses to Stress Questionnaire for Diabetes (RSQ)
timeFrame: 6 months
measure: Stress Biomarkers
timeFrame: over 3 days at baseline
measure: Stress Biomarkers
timeFrame: over 2 days at 6 months
measure: Awakening and sleep time
timeFrame: over 3 days at baseline
measure: Awakening and sleep time
timeFrame: over 2 days at 6 months
measure: Genotype & DNA Methylation
timeFrame: baseline
measure: DNA Methylation
timeFrame: 6 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Yale School of Nursing
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Margaret Grey, DrPH, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Nursing
name: Jacquelyn Taylor, PhD, PNP-BC
role: PRINCIPAL_INVESTIGATOR
References: