Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
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.
Drug: Corticorelin ovine triflutate
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures|
- cortisol levels [ Time Frame: Primarily measuring change from pre-drug baseline to peak occuring about 20 minutes to an hour later ] [ Designated as safety issue: No ]cortisol measured in saliva and in blood.
- corticotropin (ACTH) [ Time Frame: Primarily measuring change from pre-drug baseline to peak occuring about 10 minutes to an hour later ] [ Designated as safety issue: No ]ACTH will be measured in blood using chemoluminescence detection.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: laboratory HPA probes
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.
750 mcg, oral, administered twice, 3.5 hours apart
Other Name: MetopironeDrug: Dexamethasone
1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration.
Other Name: DecadronDrug: Cortrosyn
250 mcg, IV, bolus, in the afternoon.
Other Name: CosyntropinDrug: Corticorelin ovine triflutate
100 mcg, IV, over 30 seconds, in the afternoon.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673087
|Contact: Hedieh Briggs, MSWfirstname.lastname@example.org|
|Contact: Erin McRobert, MSWemail@example.com|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: James L Abelson, MD 734-764-5348 firstname.lastname@example.org|
|Principal Investigator: James L Abelson, MD|
|Principal Investigator:||James L Abelson, MD||University of Michigan|