Re-assessment of diagnostic cortisol values for adrenal insufficiency using a highly specific cortisol assay

  • STATUS
    Recruiting
  • End date
    Feb 29, 2024
  • sponsor
    Department of Endocrinology, Albert Einstein – Montefiore Medical Center
Updated on 8 January 2022
Accepts healthy volunteers

Summary

The adrenal glands are small organs that are located on top of each kidney. Normally, the adrenal glands make substances called hormones. The adrenal gland produces several different hormones that have specific functions in the body. One of these hormones is cortisol. Among other functions, cortisol in the blood helps to keep blood pressure and blood sugars normal. Cortisol is also important in the body’s stress response. Adrenal insufficiency is a condition in which the body's adrenal glands cannot produce enough cortisol. Symptoms of low cortisol can include fatigue, low blood pressure, low blood sugar, lightheadedness, nausea, and vomiting. This causes symptoms like low blood pressure and fatigue, which in some cases can become severe and even life-threatening. Therefore, it is important to accurately diagnose adrenal insufficiency. 

Description

The best way to diagnose adrenal insufficiency is through a Cosyntropin stimulation test. Cosyntropin is a synthetic version of a hormone, called adrenocorticotropic hormone (ACTH), that is secreted by the body to help produce cortisol. In the last several years, the way we analyze and measure (assay) the amount of cortisol in the blood has improved. However, with this improvement the ranges that we use to define normal and abnormal results has changed. The main purpose of our study is to re-define the levels of cortisol that accurately diagnose adrenal insufficiency using these new assays. This will help us avoid misdiagnosis.

Details
Condition *Healthy Volunteers
Clinical Study IdentifierTX290352
SponsorDepartment of Endocrinology, Albert Einstein – Montefiore Medical Center
Last Modified on8 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years or older
Healthy volunteers
Established diagnosis of primary or central adrenal insufficiency
Suspected to have primary or central adrenal insufficiency

Exclusion Criteria

Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations
Renal impairment with eGFR < 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome
Pregnant or nursing mothers
Use estrogen preparations
Major depressive disorder, severe malnutrition, anorexia, chronic fatigue syndrome
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)
Regular use of hydrocortisone cream
Use of biotin in the past 72 hours
Uncontrolled hypo- or hyperthyroidism
Regular use of fluticasone propionate or other nasal steroid inhalers (oral or nasal) in the past two weeks
Use of steroid injections in the past 6 months
Regular use of alcohol
Regular use of opioids
Regular use of suboxone
Regular use of megestrol acetate
for healthy volunteers and patients with known adrenal insufficiency only
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