Identification of Non-responders to Levothyroxine Therapy

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627611
• Other study ID #: 2017/1883 (REK)
• Secondary ID: 2017-003673-34
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2018
• Est. completion date: June 22, 2020

Study information

• Verified date: March 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Endocrine System Diseases
• Hypothyroidism

Intervention

Drug:
• Levothyroxin
3 months
• Liothyronine
3 months

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Hormonlaboratoriet, Spesialistsenteret Pilestredet Park

Country where clinical trial is conducted

Norway, 

Outcome

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