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

NCT ID: NCT01382420

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2024-05-31

Brief Summary

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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

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Conditions

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Cushing Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adrenalectomy group

patients who undergo adrenalectomy

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

adrenalectomy

Control group

patients who receive conservative treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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surgery

adrenalectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Konkuk University Medical Center

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jae Hyeon Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Hyeon Kim

Role: STUDY_DIRECTOR

Samsung Medical Center

Jung-Min Koh

Role: STUDY_CHAIR

M.D, Ph.D

Kee-Ho Song

Role: PRINCIPAL_INVESTIGATOR

M.D, Ph.D.

Yumie Rhee

Role: PRINCIPAL_INVESTIGATOR

M.D, Ph.D.

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Hyeon Kim, M.D, Ph.D.

Role: CONTACT

82-2-3410-1580

Seo Young Sohn

Role: CONTACT

82-2-3410-1582

Other Identifiers

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2011-03-034

Identifier Type: -

Identifier Source: org_study_id

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