Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

Recruiting

• Conditions: Liver Cirrhosis; Adrenal Insufficiency

• Registration Number: NCT06206655
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-03-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between total cortisol, serum free cortisol, and salivary cortisol	baseline, 30 minutes / 60minutes after synacthen injection	Difference between total cortisol, serum free cortisol, and salivary cortisol

Secondary Outcome Measures

Name	Time	Method
Correlation between serum free cortisol, salivary cortisol and steroid profile	baseline, 30 minutes / 60minutes after synacthen injection	Correlation between serum free cortisol, salivary cortisol and steroid profile

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of