Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- A1C Level
研究概览
简要总结
The purpose of this study is to determine whether mifepristone is an effective treatment for hyperglycemia due to mild hypercortisolism.
- To test the hypothesis that GR blockade with mifepristone will decrease the severity of metabolic syndrome features as measured by waist circumference, lipid profile, body mass index, blood pressure and insulin resistance, measured by HOMA-IR score.
- To test the hypothesis that GR blockade with mifepristone will improve QoL, depression and anxiety scores, measured by validated assessments, in patients with mild hypercortisolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Incidentally noted adrenal nodule <4 cm with benign imaging characteristics
- •Evidence of mild hypercortisolism
- •Evidence of diabetes or abnormal glucose tolerance
排除标准
- •contraindication to mifepristone
- •Indication for unilateral adrenalectomy
- •Evidence of other adrenal hormone hypersecretion
- •lactating mothers
- •women of childbearing age unwilling to use an effective, nonhormonal form of contraception
研究组 & 干预措施
Mifepristone
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
干预措施: Mifepristone (Drug)
结局指标
主要结局
A1C Level
时间窗: Baseline, 3 months, and 6 months
Change in hyperglycemia assessed by HbA1c, also known as glycated hemoglobin
HOMA-IR
时间窗: Baseline and 6 months
Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, HOMA-IR (a validated assessment of insulin resistance). HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
次要结局
- CushingQoL(Baseline and 6 months)
- Waist Circumference(Baseline and 6 months)
- Fasting Lipid Profile(Baseline and 6 months)
- Weight(Baseline and 6 months)
- Body Mass Index (BMI)(Baseline and 6 months)
- Nottingham Health Profile (NHP)(Baseline and 6 months)
- Quality of Life(Baseline and 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and 6 months)
- State Trait Anxiety Inventory (STAI)(Baseline and 6 months)
研究者
Alice C. Levine
Professor
Icahn School of Medicine at Mount Sinai