Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
1 other identifier
interventional
234
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 30, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 4, 2019
April 1, 2019
9 years
May 30, 2011
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of lipid profile between two groups
lipid profile with LDL,apo B
4 Year
Secondary Outcomes (1)
Incidence of obesity between two groups
4Year
Study Arms (2)
Adrenalectomy group
ACTIVE COMPARATORpatients who undergo adrenalectomy
Control group
NO INTERVENTIONpatients who receive conservative treatment
Interventions
Eligibility Criteria
You may qualify if:
- patients with both unilateral adrenal incidentaloma and hypercortisolism
- definition of hypercortisolism
- overnight dexamethasone suppression test, serum cortisol\>1.8ug/dL
- hr urine cortisol \> upper reference limit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Asan Medical Centercollaborator
- Severance Hospitalcollaborator
- Konkuk University Medical Centercollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 30, 2011
First Posted
June 27, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2020
Study Completion
May 1, 2024
Last Updated
April 4, 2019
Record last verified: 2019-04