Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

Last updated: January 19, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Wolman Disease

Hormone Deficiencies

Male Hormonal Deficiencies/abnormalities

Treatment

rapid ACTH stimulation test

Clinical Study ID

NCT06206655
2311-009-1480
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients diagnosed of liver cirrhosis

Exclusion

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 proteinwithin 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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: rapid ACTH stimulation test
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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