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

This study is currently recruiting participants.
Verified November 2015 by Jae Hyeon Kim, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382420
First Posted: June 27, 2011
Last Update Posted: November 17, 2015
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.
Collaborators:
Asan Medical Center
Severance Hospital
Konkuk University Medical Center
Information provided by (Responsible Party):
Jae Hyeon Kim, Samsung Medical Center
May 30, 2011
June 27, 2011
November 17, 2015
May 2011
May 2018   (Final data collection date for primary outcome measure)
Change of lipid profile between two groups [ Time Frame: 4 Year ]
lipid profile with LDL,apo B
Same as current
Complete list of historical versions of study NCT01382420 on ClinicalTrials.gov Archive Site
Incidence of obesity between two groups [ Time Frame: 4Year ]
measurement of body weight, height
Same as current
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cushing Syndrome
Procedure: surgery
adrenalectomy
  • Active Comparator: Adrenalectomy group
    patients who undergo adrenalectomy
    Intervention: Procedure: surgery
  • No Intervention: Control group
    patients who receive conservative treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
234
May 2018
May 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
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
 
 
NCT01382420
2011-03-034
Not Provided
Not Provided
Not Provided
Jae Hyeon Kim, Samsung Medical Center
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.
Samsung Medical Center
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP