Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients (DALI)

January 19, 2024 updated by: Jung Hee Kim, Seoul National University Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed of liver cirrhosis without exclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 30 minutes / 60minutes after synacthen injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between serum free cortisol, salivary cortisol and steroid profile
Time Frame: baseline, 30 minutes / 60minutes after synacthen injection
Correlation between serum free cortisol, salivary cortisol and steroid profile
baseline, 30 minutes / 60minutes after synacthen injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Korea Institute of Science and Technology

Investigators

  • Principal Investigator: Junghee Kim, M.D., Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2311-009-1480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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