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Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

Investigation of Incidence and Proper Diagnostic Method for Adrenal Insufficiency in Liver Cirrhosis Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06206655
Acronym
DALI
Enrollment
50
Registered
2024-01-16
Start date
2023-12-01
Completion date
2024-08-31
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency, Liver Cirrhosis

Brief summary

Patients with liver cirrhosis (LC) often exhibit fatigue, poor oral intake, and abdominal discomfort, which are the symptoms that are also shown in subjects with adrenal insufficiency (AI). Controversy exists upon over-diagnosis of adrenal insufficiency in patients with LC, because decreased albumin and/or cortisol binding protein lower total cortisol levels while free cortisol increases/or is preserved. The investigators assumed that measuring salivary cortisol or direct free cortisol using mass-spectrometry would provide a more accurate level of cortisol in LC patients. 50 patients with LC will be recruited and undergo a rapid ACTH stimulation test and their blood/ saliva will be collected and analyzed. The difference between serum free cortisol and total cortisol, as well as between salivary cortisol and total cortisol will be investigated to find the optimal way to diagnose AI in LC patients.

Interventions

DIAGNOSTIC_TESTrapid ACTH stimulation test

Take 2ml blood/saliva sample at baseline. Then, we will inject synacthen 250mcg IV to patients and collect 2ml blood/saliva after 30minutes and 60 minutes.

Sponsors

Korea Institute of Science and Technology
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients diagnosed of liver cirrhosis

Exclusion criteria

* pregnant * history of getting surgery of pituitary resection or adrenalectomy * patients with diagnosis of pituitary adenoma or adrenal adenoma * patients take steroid within 3 months * patients take medication related to synthesis of steroid or cortisol binding protein within 3 months (i.e. ketoconazole, etomidate, sex hormone, oral contraceptive) * patients take albumin, free frozen plasma, terlipressin, glypressin within 1 month * patients with acute medical condition

Design outcomes

Primary

MeasureTime frameDescription
Difference between total cortisol, serum free cortisol, and salivary cortisolbaseline, 30 minutes / 60minutes after synacthen injectionDifference between total cortisol, serum free cortisol, and salivary cortisol

Secondary

MeasureTime frameDescription
Correlation between serum free cortisol, salivary cortisol and steroid profilebaseline, 30 minutes / 60minutes after synacthen injectionCorrelation between serum free cortisol, salivary cortisol and steroid profile

Countries

South Korea

Contacts

Primary ContactMin Jeong Park
minjeong87@gmail.com01072713805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026