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Completed

NCT Number: NCT03053115

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

AziendaUSLModena

Modena, 41126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liothyronine

Drug

Cases will take liothyronine drops in the morning and two hours after dinner

levothyroxin

Drug

Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)

Placebos

Drug

Controls will take placebo two hours after dinner

Primary outcomes

  1. 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

    change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L)

Secondary outcomes

  1. BMI (kg/m2)

    Time frame: baseline and then repeated at 6, 12 weeks and 24 weeks

    body mass index

  2. quality of life changes

    Time frame: baseline and then repeated at 12 weeks and 24 weeks

    score at validated questionnaires

  3. 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 TSH serum levels at 12 and 24 weeks (microIU/ml)

  4. 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 triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L)

  5. 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 free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L)

  6. 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 total cholesterol serum levels at 12 and 24 weeks (mg/dl)

  7. 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 HDL cholesterol serum levels at 12 and 24 weeks (mg/dl)

  8. 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 triglycerides serum levels at 12 and 24 weeks (mg/dl)

  9. 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 C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl)

  10. 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 Osteocalcin at 12 and 24 weeks (ng/mL)

  11. 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

    change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L)

Sponsors and collaborators

Lead sponsor

Azienda USL Modena

Other

Registry information

Official study title

Combined Replacement Therapy With Levothyroxine and Liothyronine in Thyroidectomized Patients: Effects on Peripheral Tissues. A Prospective, Randomized, Controlled, Double-blind Study

Acronym: LEVOLIO

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Feb 14, 2017
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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