NCT06206655

Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenal Insufficiency
• Liver Cirrhosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	rapid 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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-03-31
• Completion: 2024-08-31
• First posted: 2024-01-16
• Last updated: 2024-01-22

Locations

1 site across 1 country: South Korea