Long-term Beneficial Metabolic Effects of Adrenalectomy i... | NCT01382420

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

NCT01382420

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Apr 4, 2019Actual

Enrollment

234Estimated

Phase

Not Applicable

Conditions

Cushing Syndrome

Interventions

surgery

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2020Estimated

Completion Date

May 2024Estimated

First Submitted Date

May 30, 2011

First Submission Date that Met QC Criteria

Jun 23, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2019

Last Update Posted Date

Apr 4, 2019Actual

Name	Class
Asan Medical Center	OTHER
Severance Hospital	OTHER
Konkuk University Medical Center	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

234Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adrenalectomy group	Active Comparator	patients who undergo adrenalectomy	Procedure: surgery
Control group	No Intervention	patients who receive conservative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	adrenalectomy	Adrenalectomy group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of lipid profile between two groups	lipid profile with LDL,apo B	4 Year

Secondary Outcomes

Measure	Description	Time Frame
Incidence of obesity between two groups	measurement of body weight, height	4Year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jae Hyeon Kim, M.D, Ph.D.	Contact	82-2-3410-1580		jaehyeonmd.kim@samsung.com
Seo Young Sohn	Contact	82-2-3410-1582		seoyoung.sohn@samsung.com

Overall Officials

Name	Affiliation	Role
Jae Hyeon Kim	Samsung Medical Center	Study Director
Jung-Min Koh	M.D, Ph.D	Study Chair
Kee-Ho Song

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003480	Cushing Syndrome
C538238	Adrenal incidentaloma

Ancestor Terms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided