Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients

NCT06206655 | Unknown

• 1 other identifier: 2311-009-1480
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Insufficiency; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between serum free cortisol, salivary cortisol and steroid profile

  baseline, 30 minutes / 60minutes after synacthen injection

Interventions

rapid ACTH stimulation test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed of liver cirrhosis without exclusion criteria

You may qualify if:

• patients diagnosed of liver cirrhosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Institute of Science and Technology: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related 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.

  PMID: 20332771 BACKGROUND

• 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.

  PMID: 10378804 BACKGROUND

• 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.

  PMID: 36354293 BACKGROUND

• 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.

  PMID: 34506335 BACKGROUND

• 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.

  PMID: 34028160 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/salivary samples for steroid profiling

MeSH Terms

Conditions

Adrenal Insufficiency; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junghee Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Jeong Park

CONTACT

01072713805; minjeong87@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: December 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)