Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

Liver Cirrhosis Clinical Trial

— DALI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206655
• Other study ID #: 2311-009-1480
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Seoul National University Hospital
• Contact: Min Jeong Park
• Phone: 01072713805
• Email: minjeong87[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between total cortisol, serum free cortisol, and salivary cortisol	Difference between total cortisol, serum free cortisol, and salivary cortisol	baseline, 30 minutes / 60minutes after synacthen injection
Secondary	Correlation between serum free cortisol, salivary cortisol and steroid profile	Correlation between serum free cortisol, salivary cortisol and steroid profile	baseline, 30 minutes / 60minutes after synacthen injection