Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
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, measuring tissue
markers levels, such as thyroid stimulating hormone(TSH), sex hormone binding globulin
(SHBG), total cholesterol, LDL cholesterol, lipoprotein A, osteocalcin, urinary
N-telopeptide, ferritin, myoglobin, creatine kinase, glucose 6 phosphate dehydrogenases,
angiotensin-converting enzyme (ACE). The secondary endpoints are bone and metabolic
modifications, evaluated by DEXA, quality of life, tissue specific miRNA expression,
polymorphisms of genes involved in thyroid hormones metabolism.