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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

Tracking Information
First Submitted Date  ICMJE May 30, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE May 2011
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
Change of lipid profile between two groups [ Time Frame: 4 Year ]
lipid profile with LDL,apo B
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01382420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
Incidence of obesity between two groups [ Time Frame: 4Year ]
measurement of body weight, height
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
Official Title  ICMJE Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cushing Syndrome
Intervention  ICMJE Procedure: surgery
adrenalectomy
Study Arms  ICMJE
  • Active Comparator: Adrenalectomy group
    patients who undergo adrenalectomy
    Intervention: Procedure: surgery
  • No Intervention: Control group
    patients who receive conservative treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2011)
234
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01382420
Other Study ID Numbers  ICMJE 2011-03-034
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae Hyeon Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE
  • Asan Medical Center
  • Severance Hospital
  • Konkuk University Medical Center
Investigators  ICMJE
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.
PRS Account Samsung Medical Center
Verification Date April 2019

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