A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Brown adipose tissue activation
研究概览
简要总结
The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level
详细描述
15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine substitution. Endocrinologists are split in their opinion on combination therapy with T4 and T3 on patients with poorly regulated hypothyroidism. There are no objective means, by which to identify individuals who would benefit from combination therapy. The purpose of this study is to assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and brain function. The main aim is to try to identify biomarkers reflecting different effects of T4 and T3 on cell and tissue level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Poorly regulated hypothyroidism
- •Female aged between 18 and 65 years
- •Written informed consent obtained from the patient according to national regulations
排除标准
- •Cardiovascular disease
- •Chronic liver disease
- •Chronic kidney disease
- •Any other endocrinological disease
- •Use of beta blockers
- •Pregnant or lactating females
- •Hormonal substitution other than T3 and T4
- •Known psychiatric disease
研究组 & 干预措施
T4
干预措施: Levothyroxin (Drug)
T3
干预措施: Liothyronine (Drug)
结局指标
主要结局
Brown adipose tissue activation
时间窗: 6 months
Thermal imaging of supraclavicular fossa
次要结局
- Micro-RNA, miR-92a(6 months)
- Energy expenditure(6 months)
- Fatigue Questionnaire(6 months)
- Body temperature(6 months)
- ThyPRO Questionnaire(6 months)
- Mean levels of thyroid hormones(6 months)
- SF-36 Questionnaire(6 months)
- Muscle strength(6 months)
- New biomarkers(6 months)
研究者
Erik Fink Eriksen
Professor
Oslo University Hospital