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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01382420
Recruitment Status : Recruiting
First Posted : June 27, 2011
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Asan Medical Center
Severance Hospital
Konkuk University Medical Center
Information provided by (Responsible Party):
Jae Hyeon Kim, Samsung Medical Center

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Cushing Syndrome Procedure: surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2011
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Adrenalectomy group
patients who undergo adrenalectomy
 Procedure: surgery
adrenalectomy
No Intervention: Control group
patients who receive conservative treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change of lipid profile between two groups [ Time Frame: 4 Year ]
    lipid profile with LDL,apo B


Secondary Outcome Measures :
  1. Incidence of obesity between two groups [ Time Frame: 4Year ]
    measurement of body weight, height


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382420


Contacts
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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

Locations
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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
Investigators
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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
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Responsible Party: Jae Hyeon Kim, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01382420    
Other Study ID Numbers: 2011-03-034
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Keywords provided by Jae Hyeon Kim, Samsung Medical Center:
subclinical cushing syndrome
hypercortisolism
adrenal incidentaloma
adrenalectomy
Additional relevant MeSH terms:
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Cushing Syndrome
Adrenocortical Adenoma
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
 Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Cortex Diseases