Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

Phase 2

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: Liothyronine; Drug: Levothyroxin; Drug: Placebos

• Registration Number: NCT03053115
• Lead Sponsor: Azienda USL Modena

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-14
• Study Start: 2017-03-14
• Primary Completion: 2021-09-05
• Study Completion: 2022-06-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CASES	Liothyronine	treatment with levothyroxine and liothyronine
CONTROLS	Placebos	treatment with levothyroxine and placebo
CONTROLS	Levothyroxin	treatment with levothyroxine and placebo
CASES	Levothyroxin	treatment with levothyroxine and liothyronine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
quality of life changes	baseline and then repeated at 12 weeks and 24 weeks	score at validated questionnaires
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)
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)
BMI (kg/m2)	baseline and then repeated at 6, 12 weeks and 24 weeks	body mass index
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 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 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)
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)

Trial Locations

Locations (1)

AziendaUSLModena; 🇮🇹 Modena, Italy