Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Samsung Medical Center
Asan Medical Center
Severance Hospital
Konkuk University Medical Center
Information provided by (Responsible Party):
Jae Hyeon Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
First received: May 30, 2011
Last updated: November 16, 2015
Last verified: November 2015


To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.


234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).

Condition Intervention
Cushing Syndrome
Procedure: surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Change of lipid profile between two groups [ Time Frame: 4 Year ] [ Designated as safety issue: No ]
    lipid profile with LDL,apo B

Secondary Outcome Measures:
  • Incidence of obesity between two groups [ Time Frame: 4Year ] [ Designated as safety issue: No ]
    measurement of body weight, height

Estimated Enrollment: 234
Study Start Date: May 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adrenalectomy group
patients who undergo adrenalectomy
Procedure: surgery
No Intervention: Control group
patients who receive conservative treatment


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382420

Contact: Jae Hyeon Kim, M.D, Ph.D. 82-2-3410-1580 jaehyeonmd.kim@samsung.com
Contact: Seo Young Sohn 82-2-3410-1582 seoyoung.sohn@samsung.com

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Asan Medical Center
Severance Hospital
Konkuk University Medical Center
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.
  More Information

Responsible Party: Jae Hyeon Kim, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01382420     History of Changes
Other Study ID Numbers: 2011-03-034 
Study First Received: May 30, 2011
Last Updated: November 16, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
subclinical cushing syndrome
adrenal incidentaloma

Additional relevant MeSH terms:
Adrenal Gland Diseases
Adrenal Gland Neoplasms
Adrenocortical Adenoma
Cushing Syndrome
Adrenal Cortex Diseases
Adrenal Cortex Neoplasms
Adrenocortical Hyperfunction
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on May 26, 2016