Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
研究概览
简要总结
The aim of the study is to evaluate the peripheral tissue response to the combined administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with residual thyroid function virtually absent (thyroidectomized). Cases will be treated with LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and placebo. Treatment duration: 24 weeks.
The primary endpoint will be the peripheral effect of thyroid hormones. The secondary endpoints are bone and metabolic modifications, and changes in quality of life. Moreover any changes of outcomes related to polymorphisms of genes involved in thyroid hormones metabolism will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •older than 18 years
- •capable of consent
- •able to fill in a questionnaire in italian
- •thyroidectomized
- •serum thyroglobulin levels below 0.2 ng/ml and antibodies anti-thyroglobulin undetectable (below normal range)
- •well treated taking stable doses of levothyroxine in tablets, in the previous 3 months
排除标准
- •TSH suppressive therapy
- •pregnancy
- •cardiac arrhythmias
- •severe liver, kidney or bone diseases
- •ongoing steroids treatment
- •ongoing or in the previous 12 months treatment with bone anti-resorptive, amiodarone, colestyramine or iron.
研究组 & 干预措施
CONTROLS
treatment with levothyroxine and placebo
干预措施: Levothyroxin (Drug)
CASES
treatment with levothyroxine and liothyronine
干预措施: Liothyronine (Drug)
CASES
treatment with levothyroxine and liothyronine
干预措施: Levothyroxin (Drug)
CONTROLS
treatment with levothyroxine and placebo
干预措施: Placebos (Drug)
结局指标
主要结局
change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
时间窗: baseline and then repeated at 12 weeks and 24 weeks
change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
次要结局
- change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)(baseline and then repeated at 12 weeks and 24 weeks)
- quality of life changes(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl)(baseline and then repeated at 12 weeks and 24 weeks)
- BMI (kg/m2)(baseline and then repeated at 6, 12 weeks and 24 weeks)
- change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml)(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)(baseline and then repeated at 12 weeks and 24 weeks)
- change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L)(baseline and then repeated at 12 weeks and 24 weeks)
研究者
Manuela Simoni
Director of the Unit of Endocrinology
Azienda USL Modena