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Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients (DALI)

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Seoul National University

Status

Enrolling

Conditions

Adrenal Insufficiency
Liver Cirrhosis

Treatments

Diagnostic Test: rapid ACTH stimulation test

Study type

Observational

Funder types

Other

Identifiers

NCT06206655
2311-009-1480

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Min Jeong Park

Data sourced from clinicaltrials.gov

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