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

Not Applicable

• Conditions: Cushing Syndrome
• Interventions: Procedure: surgery

• Registration Number: NCT01382420
• Lead Sponsor: Samsung Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04
• Primary Completion: 2020-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adrenalectomy group	surgery	patients who undergo adrenalectomy

Primary Outcome Measures

Name	Time	Method
Change of lipid profile between two groups	4 Year	lipid profile with LDL,apo B

Secondary Outcome Measures

Name	Time	Method
Incidence of obesity between two groups	4Year	measurement of body weight, height

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of