Investigation of Incidence and Proper Diagnostic Method for Adrenal Insufficiency in Liver Cirrhosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Difference between total cortisol, serum free cortisol, and salivary cortisol
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients diagnosed of liver cirrhosis
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Difference between total cortisol, serum free cortisol, and salivary cortisol
Time Frame: baseline, 30 minutes / 60minutes after synacthen injection
Difference between total cortisol, serum free cortisol, and salivary cortisol
Secondary Outcomes
- Correlation between serum free cortisol, salivary cortisol and steroid profile(baseline, 30 minutes / 60minutes after synacthen injection)
Investigators
Jung Hee Kim
professor
Seoul National University Hospital