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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01382420
Other study ID # 2011-03-034
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date May 2024

Study information

Verified date April 2019
Source Samsung Medical Center
Contact Jae Hyeon Kim, M.D, Ph.D.
Phone 82-2-3410-1580
Email jaehyeonmd.kim@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 234
Est. completion date May 2024
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Intervention

Procedure:
surgery
adrenalectomy

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (4)

Lead Sponsor Collaborator
Samsung Medical Center Asan Medical Center, Konkuk University Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of lipid profile between two groups lipid profile with LDL,apo B 4 Year
Secondary Incidence of obesity between two groups measurement of body weight, height 4Year
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