Cosyntropin Test for Adrenal Fatigue
Recruiting in Palo Alto (17 mi)
Overseen bySmita B Abraham, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Montefiore Medical Center
Must be taking: Glucocorticoids
Must not be taking: Estrogens, Barbiturates, Phenytoin, others
Disqualifiers: Liver impairment, Renal impairment, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using certain medications, such as estrogen preparations, medications that affect liver enzymes, and biotin within 72 hours. Healthy volunteers must also stop using glucocorticoids and certain other medications for specific periods before the trial.
What evidence supports the effectiveness of the drug Cosyntropin for adrenal fatigue?
Research shows that low doses of ACTH(1-24), a component of Cosyntropin, can effectively stimulate cortisol production, which is crucial for assessing adrenal function. This suggests that Cosyntropin may help evaluate and manage conditions related to adrenal insufficiency.
12345Is the Cosyntropin Test for Adrenal Fatigue safe for humans?
The Cosyntropin Test, using substances like tetracosactide (Synacthen), is generally safe, but rare allergic reactions, including severe anaphylactic shock, have been reported. Most studies do not report significant side effects, but caution is advised due to the potential for serious allergic reactions.
12356How does the drug cosyntropin differ from other treatments for adrenal fatigue?
Cosyntropin is unique because it is a synthetic form of adrenocorticotropic hormone (ACTH) used to test adrenal function by stimulating cortisol production. Unlike other treatments, it is primarily used for diagnostic purposes rather than as a direct treatment for adrenal fatigue, and it can be administered in different doses to assess adrenal insufficiency more accurately.
578910Eligibility Criteria
This trial is for adults over 18 who may have adrenal insufficiency, which means their bodies don't make enough cortisol. It's open to those with a suspected or confirmed diagnosis but not currently on certain steroids, opioids, or other excluded medications. Pregnant women and individuals with specific health conditions like severe liver or kidney issues can't participate.Inclusion Criteria
I am 18 or older and have never been diagnosed with adrenal insufficiency.
I am 18 or older with adrenal insufficiency confirmed by a test and I'm on glucocorticoids.
I am 18 or older and have never been diagnosed with adrenal insufficiency.
+3 more
Exclusion Criteria
I regularly use hydrocortisone cream.
I have not taken biotin in the last 3 days.
I have a condition like severe depression, malnutrition, or chronic fatigue that affects my hormone balance.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Cosyntropin Stimulation Test
Participants undergo a cosyntropin stimulation test to measure cortisol levels before and after cosyntropin administration
2 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the cosyntropin stimulation test
1 week
Participant Groups
The study aims to find the most accurate cortisol levels for diagnosing adrenal insufficiency using the cosyntropin stimulation test. This will help determine if someone's cortisol levels are too low for daily activities.
3Treatment groups
Active Control
Group I: Patients with known adrenal insufficiencyActive Control1 Intervention
This group consists of patients 18 years or older with an established diagnosis of adrenal insufficiency. Study participation by patients with adrenal insufficiency helps us understand what cortisol levels should be, in the new assays, among those with adrenal insufficiency.
Group II: Healthy volunteersActive Control1 Intervention
Healthy volunteers are those 18 years or older without prior diagnosis of adrenal insufficiency. Study participation by healthy volunteers helps us understand what cortisol levels should be in a healthy population. This information also helps us figure out what levels might be in people with adrenal insufficiency.
Group III: Patients suspected to have adrenal insufficiencyActive Control1 Intervention
This groups consists of patients 18 years or older who are suspected to have adrenal insufficiency. Study participation by this group will help us understand if the cortisol values we get from the new assay accurately diagnose adrenal insufficiency.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Montefiore Medical CenterBronx, NY
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Who Is Running the Clinical Trial?
Montefiore Medical CenterLead Sponsor
Medical College of WisconsinCollaborator
References
Comparison of low and high dose corticotropin stimulation tests in patients with pituitary disease. [2022]Tetracosactin [corticotropin-(1-24)] is used for clinical testing of adrenocortical responsiveness. The usual dose [high dose test (HDT)] is 250 micrograms. With this test, patients with mild secondary adrenal insufficiency are usually not identified, thus putting them at risk of an adrenal crisis in stressful situations. It was recently reported that a tetracosactin test with approximately 1 micrograms [low dose test (LDT)] identifies patients with mild forms of pituitary-adrenal insufficiency. We performed both the HDT and the LDT in 35 control subjects and in 44 patients with pituitary disease, mostly pituitary tumors. In these patients, more sensitive reference tests for evaluating the pituitary-adrenal axis (insulin-induced hypoglycemia, metyrapone, and CRH tests) were also performed. In the HDT, plasma cortisol was measured 30 and 60 min after tetracosactin injection; in the LDT (0.5 microgram/m2 body surface area), plasma cortisol was measured 20, 30, 40, 50, and 60 min postinjection. In 6 control subjects, tetracosactin plasma levels were also measured after injection. In the HDT, the correlation between 30 and 60 min cortisol levels was extremely high (r = 0.991; P
Profile, mean residence time of ACTH and cortisol responses after low and standard ACTH tests in healthy volunteers. [2015]No consensus exists until now about the suitable dose of tetracosactin in the ACTH stimulation test for detecting adrenal insufficiency. Our aim was to characterize both the ACTH(1-24) and the cortisol profiles after standard high-dose test (250 microg) (HDT) and low-dose test (1 microg) (LDT) in healthy subjects in order to provide a deeper knowledge about the relationship between stimulus and response.
Prolonged corticotrophic action of a synthetic substituted 1-18 ACTH. [2019]The adrenocorticotrophic effects of a synthetic corticotrophin analogue, alpha(1-18) ACTH with D-serine(1), lysine(17), and lysine amide(18) substitutions has been studied. It is effective after both intramuscular and subcutaneous administration and compared with tetracosactrin depot (Synacthen depot, Cortrosyn depot) it has a similarly prolonged time course of action-about 24 hours after 0.5 mg and 30 hours after 1 mg. Unlike tetracosactrin depot, however, it is well absorbed when given intranasally and does not produce painful reactions at the site of injection. Its prolonged time course of action does not depend on a formulation designed to delay its release from the injection site but most probably on a decreased rate of degradation in the circulation.
The use of low doses of ACTH in the investigation of adrenal function in man. [2019]We have investigated the adrenal response, in eight healthy adult men, to low doses of ACTH(1-24) in order to define a dose which will elicit a response similar to that obtained with the short Synacthen test. The studies were performed at 14.00 h and blood samples were withdrawn at 5-min intervals after an i.v. bolus injection of ACTH(1-24). The sampling interval was crucial in determining the timing of the peak response. Using sampling times of 0, 10, 15, 20, 25 and 30 min ensured detection of 47 out of 48 peaks. A dose-dependent rise in plasma cortisol concentration was observed with bolus injections of ACTH(1-24) between 30 and 250 ng/1.73 m2 body surface area. Increasing the dose to 500 ng/1.73m2 (500 times less than that used in the short Synacthen test) elicited an increment of plasma cortisol concentration of 200 nmol/l or greater in all subjects. Pretreatment with dexamethasone (1 mg) did not alter the timing of the peak cortisol concentration but blunted the increase (pretreatment: median, 159 nmol/l; range 83-239; on dexamethasone; median 62 nmol/l; range 21-207; P = 0.04). These data suggest that a dose of ACTH(1-24) of 500 ng/1.73 m2 satisfies the criteria of the short Synacthen test and may provide a useful method of investigating adrenal function.
[Investigation of adrenal function with corticotrophin-(1-23)-tricosipeptide-amide (author's transl)]. [2015]The new peptide corticotrophin-(1-23)-tricosipeptide-amide (Acethropan S) was shown to be useful in the assessment of adrenal function. Both in normal subjects and patients with adrenal insufficiency, the cortisol releasing capacity could be better evaluated with a dosage of 0.5 mg than with 0.25 mg. There were no obvious side effects induced by corticotrophin-(1-23)-tricosipeptide-amide.
[Fatal complication of intravenous administration of synthetic adrenocorticotrophin]. [2006]Synthetic 1-24adrenocorticotrophin (tetracosactid, Synacthen) is used in clinical medicine for diagnostic and therapeutic purposes. Side effects may occur due to unphysiological stimulation of endogenous adrenocortical hormone production. Allergic reactions to tetracosactid are rare. Anaphylactic shock leading to death was observed after intravenous injection of tetracosactid in a 14-year-old girl with bronchial asthma. Adrenocorticotrophin antibodies could be demonstrated after death in serum and ascitic fluid using the double antibody method.
A Single, Post-ACTH Cortisol Measurement to Screen for Adrenal Insufficiency in the Hospitalized Patient. [2019]Cosyntropin stimulation testing (CST) is used to screen patients for adrenal insufficiency (AI). Traditionally, CST includes baseline cortisol concentration, the administration of cosyntropin, and cortisol concentration at 30 and 60 minutes poststimulation. There is debate surrounding the utility of testing and cut-off points for concentrations at each time point.
[7-Methyltryptophan9]-beta-corticotropin-(1-24): a hyperactive Synacthen analogue. [2013][7-Methyltryptophan9]-beta-corticotropin-(1-24) has been synthesised. In an isolated adrenal cell bioassay, it has 2.7 times the steroidogenic activity of beta-corticotropin-(1-24) (Synacthen).
Synthetic adrenocorticotropic hormone stimulation tests in healthy neonatal foals. [2019]Cosyntropin (adrenocorticotropic hormone [ACTH]) stimulation tests are used to evaluate adrenal function. Low-dose ACTH stimulation tests are the most accurate method for diagnosing relative adrenal insufficiency in critically ill humans but have not been evaluated in foals.
A high-sensitivity test in the assessment of adrenocortical insufficiency: 10 microg vs 250 microg cosyntropin dose assessment of adrenocortical insufficiency. [2019]The short cosyntropin (synthetic ACTH) test is recognized as the best screening manoeuvre in the assessment of adrenocortical insufficiency. Recent data, however, suggest that i.v. administration of 250 microg cosyntropin could be a pharmacological rather than a physiological stimulus, losing sensitivity for detecting adrenocortical failure. Our objective was to compare 10 vs 250 microg cosyntropin in order to find differences in serum cortisol peaks in healthy individuals, the adrenocortical response in a variety of hypothalamic-pituitary-adrenal axis disorders and the highest sensitivity and specificity serum cortisol cut-off point values. The subjects were 83 healthy people and 37 patients, the latter having Addison's disease (11), pituitary adenomas (7), Sheehan's syndrome (9) and recent use of glucocorticoid therapy (10). Forty-six healthy subjects and all patients underwent low- and standard-dose cosyntropin testing. In addition, 37 controls underwent the low-dose test. On comparing low- and standard-dose cosyntropin testing in healthy subjects there were no statistical differences in baseline and peaks of serum cortisol. In the group of patients, 2 out of 11 cases of Addison's disease showed normal cortisol criterion values during the standard test but abnormal during the low-dose test. In our group of patients and controls, the statistical analysis displayed a better sensitivity of the low-dose vs standard-dose ACTH test at 30 and 60 min. In conclusion, these results suggest that the use of 10 microg rather than 250 microg cosyntropin i.v. in the assessment of suspicious adrenocortical dysfunction gives better results.