Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- difference in cognitive function before and after physical stress
研究概览
简要总结
Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects.
详细描述
As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects. Patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucose regulation
- •Age ≥ 18 years
- •Ability to comply with the study protocol
- •Capability to perform spiroergometry
排除标准
- •Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society:
- •acute myocardial infarction
- •instable angina pectoris
- •symptomatic arrhythmia
- •severe and symptomatic stenosis of the aortic valve
- •decompensated heart failure
- •acute pulmonary embolism
- •Acute myocarditis
- •Acute pericarditis
- •Acute aortic dissection
- •main coronary artery disease
- •valvulopathies
- •electrolyte disturbance
- •arterial hypertension (systolic blood pressure > 200 mm Hg, diastolic BP > 110 mm Hg)
- •Tachyarrhythmia or Bradyarrhythmia
- •Hypertrophic cardiomyopathy and other forms of obstructive heart disease
- •second or third degree atrioventricular block
- •Diabetes mellitus Type 2
- •Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
- •Glucocorticoid-pharmacotherapy
结局指标
主要结局
difference in cognitive function before and after physical stress
时间窗: testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min)
study participants are tested with three standardized tests: stroop-task, symptom rating scale and a short term memory test. First testing is performed at visit 1 at rest, the second test at visit 2 after strenuous activity at a bicycle ergometer.
次要结局
- differences in counterregulatory hormonal response to physical stress(at visit 2, blood sampling over 180 min starting 10 min before spiroergometry)
研究者
Bruno Allolio
professor of medicine, head of the department of endocrinology and diabetology
University of Wuerzburg