Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Adrenal Insufficiency Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No