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

Cushing Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01382420
• Other study ID #: 2011-03-034
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenocortical Adenoma
• Cushing Syndrome
• Syndrome

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