Identification of Non-responders to Levothyroxine Therapy

Conditions

Hypothyroidism, Biomarkers, Endocrine System Diseases

Keywords

Thyroxine, Triiodothyronine

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.

Betty Ann Bjerkreim, Sara Salehi Hammerstad, Hanne Løvdal Gulseth, Tore Julsrud Berg, Sindre Lee-Ødegård et al. (6 authors)

Journal of Thyroid Research2022-05-047 citations

10.1155/2022/6423023

Effect of Liothyronine Treatment on Quality of Life in Female Hypothyroid Patients With Residual Symptoms on Levothyroxine Therapy: A Randomized Crossover Study

Betty Ann Bjerkreim, Sara Salehi Hammerstad, Hanne Løvdal Gulseth, Tore Julsrud Berg, Lars Johan Omdal et al. (7 authors)

Frontiers in Endocrinology2022-02-2220 citations

10.3389/fendo.2022.816566

Effect of Liothyronine Treatment on Dermal Temperature and Activation of Brown Adipose Tissue in Female Hypothyroid Patients: A Randomized Crossover Study

Betty Ann Bjerkreim, Sara Salehi Hammerstad, Hanne Løvdal Gulseth, Tore Julsrud Berg, Sindre Lee-Ødegård et al. (12 authors)

Frontiers in Endocrinology2021-11-196 citations

10.3389/fendo.2021.785175

Interventions

DRUGLevothyroxin

3 months

DRUGLiothyronine

3 months

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Brown adipose tissue activation	6 months	Thermal imaging of supraclavicular fossa

Secondary

Measure	Time frame	Description
Energy expenditure	6 months	Indirect calorimetry
Muscle strength	6 months	Hand grip test
ThyPRO Questionnaire	6 months	Thyroid patient reported outcome, 13 multi-item scale, range 0-100 with higher scores indicating poorer health status
Mean levels of thyroid hormones	6 months	TSH, free T4 and free T3
Body temperature	6 months	Rectal thermometer
Fatigue Questionnaire	6 months	11 item, range 0-33 with higher scores implying higher levels of fatigue
New biomarkers	6 months	Bone marrow fat, serum and urine
Micro-RNA, miR-92a	6 months	Serum exosomes
SF-36 Questionnaire	6 months	Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status

Countries

Norway

Outcome results

None listed