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

April 3, 2019 updated by: Jae Hyeon Kim, Samsung Medical Center

Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adrenalectomy group
patients who undergo adrenalectomy
Procedure: surgery
adrenalectomy
No Intervention: Control group
patients who receive conservative treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Asan Medical Center
Konkuk University Medical Center
Severance Hospital

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

May 30, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-03-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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