NCT01382420Unknown不适用
Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Change of lipid profile between two groups
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Adrenalectomy group
Active Comparator
patients who undergo adrenalectomy
干预措施: surgery (Procedure)
Control group
No Intervention
patients who receive conservative treatment
结局指标
主要结局
Change of lipid profile between two groups
时间窗: 4 Year
lipid profile with LDL,apo B
次要结局
- Incidence of obesity between two groups(4Year)
研究者
Jae Hyeon Kim
Associate Professor
Samsung Medical Center
研究点 (1)
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