Adrenal InsufficiencyDALINCT06206655
Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients
An observational study of Adrenal Insufficiency and Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Insufficiency, Liver Cirrhosis
- What is being tested?
- rapid ACTH stimulation test
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed of liver cirrhosis without exclusion criteria
Who may be able to join
- patients diagnosed of liver cirrhosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jung Hee Kim, M.D, jhkxingfu@gmail.com
About this study
Official title: 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.
- Conditions
- Adrenal Insufficiency, Liver Cirrhosis
- Being tested
- rapid ACTH stimulation test
- Medical subject headings
- Adrenal Insufficiency, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid ACTH stimulation testDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between total cortisol, serum free cortisol, and salivary cortisol
Difference between total cortisol, serum free cortisol, and salivary cortisol
Measured: baseline, 30 minutes / 60minutes after synacthen injection
Secondary outcomes (1)
Correlation between serum free cortisol, salivary cortisol and steroid profile
Correlation between serum free cortisol, salivary cortisol and steroid profile
Measured: baseline, 30 minutes / 60minutes after synacthen injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Science and Technology
- Responsible party
- Principal investigator, Jung Hee Kim, Seoul National University Hospital
- Investigators
- Junghee Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206655
- Sponsor's protocol ID
- 2311-009-1480
- Acronym
- DALI
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20332771Wang 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.
PubMed 10378804Wentworth 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.
PubMed 36354293Tripathi 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.
PubMed 34506335Wentworth 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.
PubMed 34028160
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Incidence and Proper Diagnostic Method for Adrenal Insufficiency in Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT06206655
- Acronym / sponsor ID
- DALI / 2311-009-1480
- Conditions
- Adrenal Insufficiency, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Institute of Science and Technology
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed of liver cirrhosis without exclusion criteria
Key inclusion criteria (1 listed)
- patients diagnosed of liver cirrhosis
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid ACTH stimulation testTake 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. | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Correlation between serum free cortisol, salivary cortisol and steroid profile
Time frame: baseline, 30 minutes / 60minutes after synacthen injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 20332771Montagnese 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.
- Background: PubMed 10378804Wang 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.
- Background: PubMed 36354293Wentworth 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.
- Background: PubMed 34506335Tripathi 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.
- Background: PubMed 34028160Wentworth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junghee Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency and Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Jeong Park (01072713805, minjeong87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between total cortisol, serum free cortisol, and salivary cortisol (time frame: baseline, 30 minutes / 60minutes after synacthen injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06206655, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.