Clinical trial NCT03053115: Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients
Official title: Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypothyroidism
Keywords: thyroid
levothyroxine
combined therapy
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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.

Primary outcomes:
measure: change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
Secondary outcomes:
measure: BMI (kg/m2)
timeFrame: baseline and then repeated at 6, 12 weeks and 24 weeks
measure: quality of life changes
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
measure: change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L)
timeFrame: baseline and then repeated at 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Modena
country: Italy
facility: AziendaUSLModena
Study officials:
References: