Novel Approaches to the Treatment of Hypothyroidism
UConn Health
Summary
Hypothyroidism is a common condition, more frequent in females, associated with excess of cardiovascular risk and poor quality of life not completely abrogated by treatment with levothyroxine. There is an unmet need to define a safe, effective, and feasible regimen to be applied in large trials aimed at assessing levothyroxine/liothyronine combination therapy in patients living with hypothyroidism. To address this knowledge gap we propose a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study whose results will lay the foundation of large multicenter trial(s) able to demonstrate the effectiveness (or lack thereof) of levothyroxine/liothyronine combination therapy.
Description
Hypothyroidism is a common condition associated with excess of cardiovascular risk and poor quality of life which are not completely abrogated by treatment with levothyroxine (synthetic T4, LT4), potentially because of the inability to compensate for the loss of T3 secreted by the thyroid gland. Experimental data in animal models indicate that only combination LT4 and liothyronine (synthetic T3, LT3) can restore normal concentrations of thyroid hormones across the tissues target of the hormonal action. Clinical trials based on LT4/LT3 combination therapy and desiccated thyroid extracts (contai…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg Exclusion Criteria: Body weight \<50 or \>100 Kg. Indication for TSH suppression (high risk follicular-derived thyroid cancer). Secondary (pituitary) hypothyroidism (ICD-10 E23.0); Pregnancy; breastfeeding; uncontrolled diabetes (HbA1c \>8.5% at screening); use of oral Semaglutide (Rybelsus); Uncontrolled Hypertension (BP \> 140/90 at screening); current use of T3-containing therapies (Liothyronine, desiccated thyroid extracts). Patients receiving lipid-lowering therapies must maint…
Interventions
- DrugLevothyroxine
Patients will receive Levothyroxine/Placebo Levothyroxine/Liothyronine with Liothyronine administered twice daily.
- DrugLevothyroxine/Liothyronine once daily
Patients will receive Levothyroxine/Liothyronine with Liothyronine administered once daily;
- DrugLevothyroxine/Liothyronine twice daily
Patients will receive Levothyroxine/Liothyronine with Liothyronine administered twice daily;
Location
- UConn HealthFarmington, Connecticut