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

Primary Purpose

Cushing Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
surgery
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing Syndrome focused on measuring subclinical cushing syndrome, hypercortisolism, adrenal incidentaloma, adrenalectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Adrenalectomy group

Control group

Arm Description

patients who undergo adrenalectomy

patients who receive conservative treatment

Outcomes

Primary Outcome Measures

Change of lipid profile between two groups
lipid profile with LDL,apo B

Secondary Outcome Measures

Incidence of obesity between two groups
measurement of body weight, height

Full Information

First Posted
May 30, 2011
Last Updated
April 3, 2019
Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Severance Hospital, Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01382420
Brief Title
Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
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 Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Severance Hospital, Konkuk University Medical Center

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Syndrome
Keywords
subclinical cushing syndrome, hypercortisolism, adrenal incidentaloma, adrenalectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adrenalectomy group
Arm Type
Active Comparator
Arm Description
patients who undergo adrenalectomy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients who receive conservative treatment
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
adrenalectomy
Primary Outcome Measure Information:
Title
Change of lipid profile between two groups
Description
lipid profile with LDL,apo B
Time Frame
4 Year
Secondary Outcome Measure Information:
Title
Incidence of obesity between two groups
Description
measurement of body weight, height
Time Frame
4Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyeon Kim, M.D, Ph.D.
Phone
82-2-3410-1580
Email
jaehyeonmd.kim@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seo Young Sohn
Phone
82-2-3410-1582
Email
seoyoung.sohn@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hyeon Kim
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jung-Min Koh
Organizational Affiliation
M.D, Ph.D
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kee-Ho Song
Organizational Affiliation
M.D, Ph.D.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yumie Rhee
Organizational Affiliation
M.D, Ph.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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