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 June 2011 by Samsung Medical Center
Sponsor:
Collaborators:
Asan Medical Center
Severance Hospital
Konkuk University Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01382420
First received: May 30, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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 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 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
adrenalectomy
No Intervention: Control group
patients who receive conservative treatment

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
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

Contacts
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
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
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

No publications provided

Responsible Party: Jae Hyeon Kim, 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: June 23, 2011
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014