Metabolic, Pressor and Neuropsychological Effects of Metyrapone Treatment in Patients With Hypercortisolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients with a mean systolic BP reduction of ≥5 mm Hg
研究概览
简要总结
The aims of the present study are to evaluate in patients with mild hypercortisolism the effect of metyrapone treatment on glycometabolic control, blood pressure, thrombotic risk parameters, lipid profile, bone turnover markers, mental health and cortisol circadian rhythm.
详细描述
This open prospective observational study will include patients with mild hypercortisolism of both adrenal and pituitary origin not candidate for surgery. Patients taking metyrapone since less than a week will be followed up for 24 weeks. During this period of time, patients will be re-evaluated as far as blood pressure control, glycometabolic control, thrombotic risk parameters, lipid profile, bone turnover markers and cortisol circadian rhythm is concerned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild Cushing's Syndrome not candidate for surgery
- •Current therapy with metyrapone since less than 1 week
- •Cortisol levels at 08:00 after 1 mg-overnight dexamethasone suppression test (1mgDST) >1.8 μg/dL
- •Confirmed with 2 mg two days dexamethasone suppression test (2mgx2dDST)
- •Presence of at least one out of the following conditions: type 2 diabetes mellitus, impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), arterial hypertension, bone mineral density (BMD) Z-score < -2.0 and/or fragility fracture at any skeletal site
- •Stable anti-hypertensive therapies and blood pressure (BP) levels in the month before enrolment
- •Stable anti-diabetic therapies and glycometabolic control during the month before enrolment
- •Stable body weight during the month before enrolment
排除标准
- •Signs and/or symptoms of overt hypercortisolism (striae rubrae, moon facies, easy bruising, buffalo hump, hypertrichosis)
- •Malignant hypertension and/or BP <200/120 mmHg
- •Severe hyperglycemia (i.e. FG >350 mg/dL)
- •Urinary free cortisol (UFC) higher than 1.5 fold the upper normal range
- •Presence of pheochromocytoma or primary hyperaldosteronism
- •Possible adrenal metastases or radiological features suggestive for adrenal malignancy (i.e. not homogeneous pattern, necrosis, calcifications, irregular margins, local invasion and high density at computed tomography)
- •Congenital adrenal hyperplasia
- •Intake of drugs influencing cortisol metabolism and/or secretion
- •Women in child-bearing age
- •Patients with body mass index (BMI) >35 kg/m2
研究组 & 干预措施
metyrapone treatment
hypercortisolemic patients taking metyrapone since less than a week (usually 250 mg/day, maximum dose 6000 mg/day)
干预措施: Metyrapone Capsules (Drug)
结局指标
主要结局
Proportion of patients with a mean systolic BP reduction of ≥5 mm Hg
时间窗: Baseline, 24 weeks
BP levels will be measured with arterial blood pressure monitoring (ABPM)
次要结局
- Changes in glycometabolic control(12 and 24 weeks)
- Normalization of cortisol circadian rhythm(baseline, 12 weeks, 24 weeks.)
- Changes of lipid profile(Baseline, 12 and 24 weeks)
- Changes of bone turnover markers(Baseline, 12 and 24 weeks)
- Amelioration of psychological symptoms(Baseline, 12 and 24 weeks)
- Changes of thrombotic risk parameters(Baseline, 12 and 24 weeks)