Hypothyroidism
Conditions
Keywords
thyroid, levothyroxine, combined therapy
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.
Interventions
DRUGLiothyronine
Cases will take liothyronine drops in the morning and two hours after dinner
DRUGLevothyroxin
Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)
DRUGPlacebos
Controls will take placebo two hours after dinner
Sponsors
Azienda USL Modena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L) | baseline and then repeated at 12 weeks and 24 weeks | change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life changes | baseline and then repeated at 12 weeks and 24 weeks | score at validated questionnaires |
| 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 TSH serum levels at 12 and 24 weeks (microIU/ml) |
| 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 free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L) |
| 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 free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L) |
| 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 total cholesterol serum levels at 12 and 24 weeks (mg/dl) |
| BMI (kg/m2) | baseline and then repeated at 6, 12 weeks and 24 weeks | body mass index |
| change from baseline triglycerides 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) |
| 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 | change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl) |
| change from baseline Osteocalcin at 12 and 24 weeks (ng/mL) | baseline and then repeated at 12 weeks and 24 weeks | change from baseline Osteocalcin at 12 and 24 weeks (ng/mL) |
| change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L) | baseline and then repeated at 12 weeks and 24 weeks | change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L) |
| 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 HDL cholesterol serum levels at 12 and 24 weeks (mg/dl) |
Countries
Italy
Outcome results
None listed