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

Samsung Medical Center

Status: Unknown

Conditions: Cushing Syndrome

Treatments: Procedure: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01382420

2011-03-034

Details and patient eligibility

About

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).

Enrollment: 234 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Adrenalectomy group

Active Comparator group

Description:

patients who undergo adrenalectomy

Treatment:

Procedure: surgery

Control group

No Intervention group

Description:

patients who receive conservative treatment