Clinical trial NCT06206655: Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients
Official title: Investigation of Incidence and Proper Diagnostic Method for Adrenal Insufficiency in Liver Cirrhosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Insufficiency
Liver Cirrhosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Institute of Science and Technology
First posted: 2024-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed of liver cirrhosis without exclusion criteria

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between total cortisol, serum free cortisol, and salivary cortisol
timeFrame: baseline, 30 minutes / 60minutes after synacthen injection
Secondary outcomes:
measure: Correlation between serum free cortisol, salivary cortisol and steroid profile
timeFrame: baseline, 30 minutes / 60minutes after synacthen injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Junghee Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montagnese S, Middleton B, Mani AR, Skene DJ, Morgan MY. On the origin and the consequences of circadian abnormalities in patients with cirrhosis. Am J Gastroenterol. 2010 Aug;105(8):1773-81. doi: 10.1038/ajg.2010.86. Epub 2010 Mar 23.
citation: Wang S, Cukierman E, Swaim WD, Yamada KM, Baum BJ. Extracellular matrix protein-induced changes in human salivary epithelial cell organization and proliferation on a model biological substratum. Biomaterials. 1999 Jun;20(11):1043-9. doi: 10.1016/s0142-9612(98)00255-5.
citation: Wentworth BJ, Schliep M, Novicoff W, Siragy HM, Geng CX, Henry ZH. Relative adrenal insufficiency in the non-critically ill patient with cirrhosis: A systematic review and meta-analysis. Liver Int. 2023 Mar;43(3):660-672. doi: 10.1111/liv.15473. Epub 2022 Nov 21.
citation: Tripathi PR, Sen Sarma M, Yachha SK, Aggarwal A, Bhatia V, Kumar A, Srivastava A, Poddar U. Relative Adrenal Insufficiency in Decompensated Cirrhotic Children: Does It Affect Outcome? Am J Gastroenterol. 2022 Jan 1;117(1):120-128. doi: 10.14309/ajg.0000000000001486.
citation: Wentworth BJ, Haug RM, Northup PG, Caldwell SH, Henry ZH. Abnormal cholesterol metabolism underlies relative adrenal insufficiency in decompensated cirrhosis. Liver Int. 2021 Aug;41(8):1913-1921. doi: 10.1111/liv.14970. Epub 2021 Jun 8.