NCT03379181已完成4 期
Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism
研究概览
简要总结
The overall objective of the HEAT study is to determine the acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism and to evaluate the consequences of the change of hyper- to euthyroidism on metabolism during the course of treatment, especially with regard to the reaction to cold ambient temperatures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Age 18 to 70 years
- •Hyperthyroidism: Thyroid-stimulating Hormone (TSH) below 0.2 mU and free T4 at or above 25 pmol/L or free T3 at or above 8 pmol/L.
排除标准
- •Contraindications to propranolol: hypersensitivity or allergy
- •Therapy with a beta blocker for reasons other than hyperthyroidism (e.g. cardiac arrhythmia or heart failure)
- •Treatment with amiodarone
- •Women who are pregnant or breast feeding,
- •Intention to become pregnant during the course of the study,
- •History of asthma or chronic obstructive pulmonary disease
- •Occlusive peripheral artery disease; Raynaud's syndrome.
- •Other clinically significant concomitant disease states:
- •Known renal failure (GFR < 50 ml/min)
- •Known hepatic dysfunction
- •known heart failure or unstable angina pectoris
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
- •ECG-criteria
- •Resting heart rate below 60 bpm
- •Complete left bundle branch block
- •Atrioventricular block (AV-block) grade 2 or 3
研究组 & 干预措施
Propranolol 80 mg
Experimental
Patients receive a single dose of 80 mg propranolol p.o.
干预措施: Propranolol (Drug)
结局指标
主要结局
acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism
时间窗: 90 minutes after propranolol application
difference in resting energy expenditure (REE) measured single 90 minutes after an oral dose of 80 mg of propranolol compared to resting energy expenditure measured during the thirty minutes prior to administration of propranolol (ΔREEPropranolol).
次要结局
- Change in Body composition: percent body fat(after 3 to 4 months)
- Cold induced thermogenesis (CIT) in patients with hyperthyroidism(after 3 to 4 months)
- Difference in REE hyperthyroid state to euthyroid state(after 6 to 7 months)
- Respiratory quotient (RQ) before and after administration of propranolol.(90 minutes after propranolol application)
- Difference in REE from hyperthyroid to euthyroid state(after 3 to 4 months)
- Difference in skin temperature(90 minutes after propranolol application)
研究者
研究点 (1)
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