Identification of Non-responders to Levothyroxine Therapy

Phase 2

Completed

• Conditions: Hypothyroidism; Biomarkers; Endocrine System Diseases
• Interventions: Drug: Levothyroxin; Drug: Liothyronine

• Registration Number: NCT03627611
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-13
• Study Start: 2018-08-14
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T4	Levothyroxin	-
T3	Liothyronine	-

Primary Outcome Measures

Name	Time	Method
Brown adipose tissue activation	6 months	Thermal imaging of supraclavicular fossa

Secondary Outcome Measures

Name	Time	Method
Energy expenditure	6 months	Indirect calorimetry
Fatigue Questionnaire	6 months	11 item, range 0-33 with higher scores implying higher levels of fatigue
Body temperature	6 months	Rectal thermometer
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
SF-36 Questionnaire	6 months	Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status
Muscle strength	6 months	Hand grip test
New biomarkers	6 months	Bone marrow fat, serum and urine
Micro-RNA, miR-92a	6 months	Serum exosomes

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway