Cushing SyndromeNCT01382420
Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
A study testing surgery in people with Cushing Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Objective: To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma. Methods: 234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cushing Syndrome
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to May 2024
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with both unilateral adrenal incidentaloma and hypercortisolism
- definition of hypercortisolism
- overnight dexamethasone suppression test, serum cortisol>1.8ug/dL
- 24hr urine cortisol > upper reference limit
Who cannot join
- patients who took medication influencing cortisol secretion
- patients with definite clinical feature of cushing syndrome
- moon face
- abdominal striae
- skin or proximal muscle atrophy
- metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease
Show all 14Show fewer
- patients who took following medication
- insulin
- oral hypoglycemic agent
- thyroid hormone
- anti-hyperlipidemic drug
- sex hormone
- patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year
- psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
Objective:
To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.
Methods:
234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).
- Conditions
- Cushing Syndrome
- Being tested
- surgery
- Keywords
- subclinical cushing syndrome, hypercortisolism, adrenal incidentaloma, adrenalectomy
- Medical subject headings
- Cushing Syndrome, Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| Adrenalectomy group | Active comparator | patients who undergo adrenalectomy Receives: Procedure: surgery |
| Control group | No intervention | patients who receive conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of lipid profile between two groups
lipid profile with LDL,apo B
Measured: 4 Year
Secondary outcomes (1)
Incidence of obesity between two groups
measurement of body weight, height
Measured: 4Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2020 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital, Konkuk University Medical Center
- Responsible party
- Principal investigator, Jae Hyeon Kim, Samsung Medical Center
- Investigators
- Jae Hyeon Kim, Study director, Samsung Medical CenterJung-Min Koh, Study chair, M.D, Ph.DKee-Ho Song, Principal investigator, M.D, Ph.D.Yumie Rhee, Principal investigator, M.D, Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382420
- Sponsor's protocol ID
- 2011-03-034
- Status last verified
- Apr 2019
- First submitted
- 30 May 2011
- Last updated
- 4 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
- ClinicalTrials.gov ID
- NCT01382420
- Acronym / sponsor ID
- 2011-03-034
- Conditions
- Cushing Syndrome
- Keywords
- subclinical cushing syndrome, hypercortisolism, adrenal incidentaloma, adrenalectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Asan Medical Center, Severance Hospital, Konkuk University Medical Center
- Study start
- May 2011
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 27 Jun 2011 (estimated)
- 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.
Objective:
To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.
Methods:
234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenalectomy group | Active comparator | Procedure: surgerypatients who undergo adrenalectomy |
| Control group | No intervention | –patients who receive conservative treatment |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with both unilateral adrenal incidentaloma and hypercortisolism
- definition of hypercortisolism
Key exclusion criteria (14 listed)
- patients who took medication influencing cortisol secretion
- patients with definite clinical feature of cushing syndrome
- metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease
- patients who took following medication
- patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year
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 |
|---|---|---|
| surgeryadrenalectomy | Procedure or surgery | Adrenalectomy group |
Primary outcome
Change of lipid profile between two groups
Time frame: 4 Year
lipid profile with LDL,apo B
1 secondary outcome
Incidence of obesity between two groups
Time frame: 4Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Jae Hyeon Kim study director
Samsung Medical Center
Jung-Min Koh study chair
M.D, Ph.D
Kee-Ho Song principal investigator
M.D, Ph.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Cushing Syndrome, run by Samsung Medical Center 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 4 inclusion and 14 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 4 Apr 2019. 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 Jae Hyeon Kim, M.D, Ph.D. (82-2-3410-1580, jaehyeonmd.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lipid profile between two groups (time frame: 4 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.