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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003673-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Hormonlaboratoriet | UNKNOWN |
| Spesialistsenteret Pilestredet Park | UNKNOWN |
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The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4 | Active Comparator |
| |
| T3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxin | Drug | 3 months |
| |
| Liothyronine |
| Measure | Description | Time Frame |
|---|---|---|
| Brown adipose tissue activation | Thermal imaging of supraclavicular fossa | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body temperature | Rectal thermometer | 6 months |
| Energy expenditure | Indirect calorimetry | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Fink Eriksen, Professor | Department of Endocrinology, Morbid Obesity and Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35572853 | Derived | 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. | |
| 35273566 | Derived |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D014284 | Triiodothyronine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Drug |
3 months |
|
| Muscle strength | Hand grip test | 6 months |
| ThyPRO Questionnaire | Thyroid patient reported outcome, 13 multi-item scale, range 0-100 with higher scores indicating poorer health status | 6 months |
| Mean levels of thyroid hormones | TSH, free T4 and free T3 | 6 months |
| SF-36 Questionnaire | Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status | 6 months |
| Fatigue Questionnaire | 11 item, range 0-33 with higher scores implying higher levels of fatigue | 6 months |
| New biomarkers | Bone marrow fat, serum and urine | 6 months |
| Micro-RNA, miR-92a | Serum exosomes | 6 months |
| 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. |
| 34867829 | Derived | 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. |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013970 | Thyronines |