A Phase 2/3 interventional study of Liothyronine and Levothyroxin in Hypothyroidism, sponsored by Azienda USL Modena. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Azienda USL Modena · Phase 2/3, Interventional, and Treatment
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.
Exclusion Criteria:
treatment with levothyroxine and liothyronine
Drug: Liothyronine · Drug: Levothyroxin
treatment with levothyroxine and placebo
Drug: Levothyroxin · Drug: Placebos
Cases will take liothyronine drops in the morning and two hours after dinner
Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)
Controls will take placebo two hours after dinner
change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)
Time frame: baseline and then repeated at 12 weeks and 24 weeks
BMI (kg/m2)
body mass index
Time frame: baseline and then repeated at 6, 12 weeks and 24 weeks
quality of life changes
score at validated questionnaires
Time frame: 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 TSH serum levels at 12 and 24 weeks (microIU/ml)
Time frame: 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 triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)
Time frame: 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 free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)
Time frame: baseline and then repeated at 12 weeks and 24 weeks
change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)
change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl)
Time frame: baseline and then repeated at 12 weeks and 24 weeks
change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)
change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)
Time frame: 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 triglycerides serum levels at 12 and 24 weeks (mg/dl)
Time frame: 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 C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)
Time frame: baseline and then repeated at 12 weeks and 24 weeks
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
change from baseline Osteocalcin at 12 and 24 weeks (ng/mL)
Time frame: 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 Bone alkaline phosphatase at 12 and 24 weeks (µg/L)
Time frame: baseline and then repeated at 12 weeks and 24 weeks
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda USL Modena