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New treatment option for Adrenal Insufficiency
Official title Updated Diagnostic Cortisol Values for Adrenal Insufficiency
ClinicalTrials.gov ID: NCT05149638
What this study is testing
- What it's testing
- The purpose of this study is to determine the cortisol levels that most accurately diagnose a patient with adrenal insufficiency, a condition in which cortisol levels are too low for daily living.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for healthy volunteers:
- \- Male and female outpatients 18 years or older without prior diagnosis of primary or central adrenal insufficiency
- for patients with known adrenal insufficiency:
- \- Males and females 18 years or older with established diagnosis of primary or central adrenal insufficiency as previously documented in the...
- for patients with suspected adrenal insufficiency:
You likely can't join if
- for all groups:
- Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome
- Pregnancy or nursing mothers
- Use of estrogen preparations
- Uncontrolled major depressive disorder or psychiatric diseases, severe malnutrition, eating disorders, chronic fatigue syndrome (disorders that alter...
See the full eligibility criteria
- for healthy volunteers:
- \- Male and female outpatients 18 years or older without prior diagnosis of primary or central adrenal insufficiency
- for patients with known adrenal insufficiency:
- \- Males and females 18 years or older with established diagnosis of primary or central adrenal insufficiency as previously documented in the electronic medical record by a failed CST (peak cortisol level \< 18 μg/dL)...
- for patients with suspected adrenal insufficiency:
- \- Males and females 18 years or older with suspected diagnosis of primary or central adrenal insufficiency by any cause based on clinical evaluation by a study team member. Inpatients with non-critical illness and...
- for all groups:
- Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome
- Pregnancy or nursing mothers
- Use of estrogen preparations
- Uncontrolled major depressive disorder or psychiatric diseases, severe malnutrition, eating disorders, chronic fatigue syndrome (disorders that alter hypothalamic-pituitary-adrenal (HPA) axis function)
- Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, aminoglutethimide and mitotane
- Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable)
- Uncontrolled hypo- or hyperthyroidism
- Use of biotin within the past 72 hours
- Regular alcohol and/or cannabis use
- History of bilateral adrenalectomy
- Treatment for validated primary adrenal insufficiency for greater than 6 months
- Be assessed by the investigators as unsuitable for participation in this study for any reason Additional Exclusion Criteria for healthy volunteers only:
- Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit
- Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks
- Regular use of any steroid creams, gels, ointments, or lotions
- Use of steroid (glucocorticoid) injections in the past 6 months (healthy volunteers)
- Regular use of opioids
- Regular use of suboxone
- Regular use of megestrol acetate
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.