The Role of Glucocorticoid Receptor SNPs in Receptor Function and Metabolic Disease
Completed
Conditions studied: Glucose Homeostasis, Protein Metabolism, Lipid Metabolism, Respiratory Function, Connective Tissue Metabolism
In brief
Background: \- Glucocorticoids are primary stress response hormones released from the adrenal gland when an individual is under stress. Chronic or ongoing elevation of these hormones due to prolonged stress or medical treatments can have numerous harmful effects. Researchers are interested in learning more about how these hormones affect cell growth, development, and death. To study glucocorticoid hormones, researchers plan to use the medication dexamethasone, which affects the parts of cells that respond to glucocorticoid hormones. Objectives: \- To study glucocorticoid stress hormones in healthy individuals before and after receiving dexamethasone. Eligibility: * Healthy individuals at least 18 years of age. * Participants must not be using certain medications that may affect the dexamethasone test, including hormonal contraception, steroid-based drugs, and some antidepressants. Design: * This study will require an initial screening visit and a second study visit. The visits are estimated to require about 1 to 2 hours of participation over a period of up to 14 days. * Participants will be screened at visit 1 with a full physical examination and medical history, and an initial blood sample for testing. * For visit 2, participants will be asked to abstain from all food and drinks except for water for 12 hours before the appointment, and will take one tablet of dexamethasone 9 hours before the appointment. * Participants will have a second blood sample taken during visit 2, and will receive a snack after the blood is drawn.
Key facts
- Study ID
- NCT01143493
- Run by
- National Institute of Environmental Health Sciences (NIEHS)
- People needed
- 278
- Starts
- 2010-09-30
- Expected to finish
- 2019-12-02
- Last updated by the study team
- 2019-12-04
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Exclusion Criteria for Part 1
- Participants with the following history will be excluded from part 1 of the study:
- Any glucocorticoid use within approximately 14 days of scheduled visit 1 including oral, inhaled, nasal sprays, and cream (dermal/mucosal)
- Pregnant or currently breastfeeding
- Planning to use certain medications because they can affect test results.
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications.
- Exclusion Criteria for Part 2
- Participants with the following history will be excluded from part 2 of the study to avoid confounding the dexamethasone suppression test:
- Any glucocorticoid use within approximately 14 days of scheduled visit 2 including oral, inhaled, nasal sprays, and cream (dermal/mucosal)
- Pregnant or currently breastfeeding
- Currently enrolled in another clinical research study and/or is receiving an investigational agent for any reason
- Does not agree to take dexamethasone at scheduled time
- Planning to use certain medications such as corticosteroids, estrogens, or tetracyclines prior to the visit 2, because they can affect test results. If the participant is willing to withhold these medications for 14 days, then the participant will be allowed to participate in visit 2.
- Participants with the following history will be excluded from part 2 of the study because the dexamethasone may cause potential harm to the participant:
- High blood pressure of 160/10 mm Hg or above.
- Active coronary artery disease (angina) or moderate to severe heart failure stage New York Heart Association III-IV
- Renal failure
- Glaucoma
- Uncontrolled psychiatric disorders such as bipolar disorder or schizoaffective disorder
- Active systemic fungal infection
- Prior hypersensitivity reaction to Dexamethasone
- Currently receiving treatment for cancer (certain cancers, like lung cancer make adrenocorticotropic hormone (ACTH), and all induce stress)
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications
Where it is running
- NIEHS Clinical Research Unit (CRU) — Research Triangle Park, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.