Skip to main content
OpenTrials
Completed

NCT Number: NCT03627611

Identification of Non-responders to Levothyroxine Therapy

The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypothyroidism Biomarkers Endocrine System Diseases Thyroid Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Oslo University Hospital

Oslo, Norway

About this study

15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine substitution. Endocrinologists are split in their opinion on combination therapy with T4 and T3 on patients with poorly regulated hypothyroidism. There are no objective means, by which to identify individuals who would benefit from combination therapy. The purpose of this study is to assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and brain function. The main aim is to try to identify biomarkers reflecting different effects of T4 and T3 on cell and tissue level.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Poorly regulated hypothyroidism
  • Female aged between 18 and 65 years
  • Written informed consent obtained from the patient according to national regulations

Exclusion criteria

  • Cardiovascular disease
  • Chronic liver disease
  • Chronic kidney disease
  • Any other endocrinological disease
  • Use of beta blockers
  • Pregnant or lactating females
  • Hormonal substitution other than T3 and T4
  • Known psychiatric disease

Treatment and study plan

levothyroxin

Drug

3 months

liothyronine

Drug

3 months

Primary outcomes

  1. Brown adipose tissue activation

    Time frame: 6 months

    Thermal imaging of supraclavicular fossa

Secondary outcomes

  1. Body temperature

    Time frame: 6 months

    Rectal thermometer

  2. Energy expenditure

    Time frame: 6 months

    Indirect calorimetry

  3. Muscle strength

    Time frame: 6 months

    Hand grip test

  4. ThyPRO Questionnaire

    Time frame: 6 months

    Thyroid patient reported outcome, 13 multi-item scale, range 0-100 with higher scores indicating poorer health status

  5. Mean levels of thyroid hormones

    Time frame: 6 months

    TSH, free T4 and free T3

  6. SF-36 Questionnaire

    Time frame: 6 months

    Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status

  7. Fatigue Questionnaire

    Time frame: 6 months

    11 item, range 0-33 with higher scores implying higher levels of fatigue

  8. New biomarkers

    Time frame: 6 months

    Bone marrow fat, serum and urine

  9. Micro-RNA, miR-92a

    Time frame: 6 months

    Serum exosomes

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Hormonlaboratoriet
  • Spesialistsenteret Pilestredet Park

Registry information

Official study title

A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
Mar 17, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.