Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda USL Modena

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.