Clinical trial NCT03627611: Identification of Non-responders to Levothyroxine Therapy
Official title: A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypothyroidism
Biomarkers
Endocrine System Diseases
Keywords: Thyroxine
Triiodothyronine
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Hormonlaboratoriet
name: Spesialistsenteret Pilestredet Park
First posted: 2018-08-13
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Brown adipose tissue activation
timeFrame: 6 months
Secondary outcomes:
measure: Body temperature
timeFrame: 6 months
measure: Energy expenditure
timeFrame: 6 months
measure: Muscle strength
timeFrame: 6 months
measure: ThyPRO Questionnaire
timeFrame: 6 months
measure: Mean levels of thyroid hormones
timeFrame: 6 months
measure: SF-36 Questionnaire
timeFrame: 6 months
measure: Fatigue Questionnaire
timeFrame: 6 months
measure: New biomarkers
timeFrame: 6 months
measure: Micro-RNA, miR-92a
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of Endocrinology, Morbid Obesity and Preventive Medicine
name: Erik Fink Eriksen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Lee-Odegard S, Eriksen EF. Thyroid Signaling Biomarkers in Female Symptomatic Hypothyroid Patients on Liothyronine versus Levothyroxine Monotherapy: A Randomized Crossover Trial. J Thyroid Res. 2022 May 4;2022:6423023. doi: 10.1155/2022/6423023. eCollection 2022.
citation: Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Omdal LJ, Lee-Odegard S, Eriksen EF. Effect of Liothyronine Treatment on Quality of Life in Female Hypothyroid Patients With Residual Symptoms on Levothyroxine Therapy: A Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 Feb 22;13:816566. doi: 10.3389/fendo.2022.816566. eCollection 2022.
citation: Bjerkreim BA, Hammerstad SS, Gulseth HL, Berg TJ, Lee-Odegard S, Rangberg A, Jonassen CM, Budge H, Morris D, Law J, Symonds M, Eriksen EF. Effect of Liothyronine Treatment on Dermal Temperature and Activation of Brown Adipose Tissue in Female Hypothyroid Patients: A Randomized Crossover Study. Front Endocrinol (Lausanne). 2021 Nov 19;12:785175. doi: 10.3389/fendo.2021.785175. eCollection 2021.