- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01382420
Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
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).
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jae Hyeon Kim, M.D, Ph.D.
- Phone Number: 82-2-3410-1580
- Email: jaehyeonmd.kim@samsung.com
Study Contact Backup
- Name: Seo Young Sohn
- Phone Number: 82-2-3410-1582
- Email: seoyoung.sohn@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Adrenalectomy group
patients who undergo adrenalectomy
|
adrenalectomy
|
No Intervention: Control group
patients who receive conservative treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of lipid profile between two groups
Time Frame: 4 Year
|
lipid profile with LDL,apo B
|
4 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of obesity between two groups
Time Frame: 4Year
|
measurement of body weight, height
|
4Year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jae Hyeon Kim, Samsung Medical Center
- Study Chair: Jung-Min Koh, M.D, Ph.D
- Principal Investigator: Kee-Ho Song, M.D, Ph.D.
- Principal Investigator: Yumie Rhee, M.D, Ph.D.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-03-034
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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