Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
- Conditions
- Stress
- Interventions
- Registration Number
- NCT01673087
- Lead Sponsor
- University of Michigan
- Brief Summary
Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient way to evaluate the biological impact of day-to-day stressors that people encounter as they go about their lives, since saliva is so easy to collect. However, the biological meaning of saliva cortisol measures has never been carefully examined. The goal of this study is to collect saliva from a large group of people as they go about their every-day lives, to measure their cortisol levels, and then study them in the laboratory where Investigators can learn more about how their stress response system (which produces cortisol) is really functioning. Investigators can then determine much more precisely what saliva cortisol levels really mean in terms of stress system biology. This will allow investigators to obtain much more useful information from the next decade of research on naturalistic stress and its biological impact using saliva cortisol measures, helping investigators to understand how stress undermines health and how to combat this effect.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- Medically healthy volunteers, ages 18 to 50 years
- Pregnancy
- Irregular menses, medications or drugs that effect HPA axis
- Most psychiatric disorders
- Medical problems that effect HPA axis or increase risks involved in participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description laboratory HPA probes Cortrosyn All subjects will be studied with multiple probes of HPA axis function over the course of one to two months: Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus. laboratory HPA probes Corticorelin ovine triflutate All subjects will be studied with multiple probes of HPA axis function over the course of one to two months: Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus. laboratory HPA probes Metyrapone All subjects will be studied with multiple probes of HPA axis function over the course of one to two months: Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus. laboratory HPA probes Dexamethasone All subjects will be studied with multiple probes of HPA axis function over the course of one to two months: Metyrapone, oral, 750 mg, administered twice 3.5 hrs apart; Dexamethasone, oral, 1.5 mg administered once; oral, 0.25 mg administered once; Corticorelin ovine triflutate (CRH), intravenous, 100 mcg, administered once over 30 seconds; Cortrosyn (ACTH), intravenous, 250 mcg, administered once by bolus.
- Primary Outcome Measures
Name Time Method cortisol levels Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later cortisol measured in saliva and in blood.
- Secondary Outcome Measures
Name Time Method corticotropin (ACTH) Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later ACTH will be measured in blood using chemoluminescence detection.
Trial Locations
- Locations (1)
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States