Identification of Non-responders to Levothyroxine Therapy

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03627611
• Collaborator: Hormonlaboratoriet (Other), Spesialistsenteret Pilestredet Park (Other)
• Enrollment: 69
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.3
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism; Biomarkers; Endocrine System Diseases	Drug: Levothyroxin; Drug: Liothyronine	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine
• Actual Study Start Date: Aug 14, 2018
• Actual Primary Completion Date: Jun 22, 2020
• Actual Study Completion Date: Jun 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: T4	Drug: Levothyroxin; 3 months
Experimental: T3	Drug: Liothyronine; 3 months

Outcome Measures

Primary Outcome Measures

1. Brown adipose tissue activation [6 months]

   Thermal imaging of supraclavicular fossa

Secondary Outcome Measures

1. Body temperature [6 months]

   Rectal thermometer

2. Energy expenditure [6 months]

   Indirect calorimetry

3. Muscle strength [6 months]

   Hand grip test

4. ThyPRO Questionnaire [6 months]

   Thyroid patient reported outcome, 13 multi-item scale, range 0-100 with higher scores indicating poorer health status

5. Mean levels of thyroid hormones [6 months]

   TSH, free T4 and free T3

6. SF-36 Questionnaire [6 months]

   Short form health survey, 8 multi-item scale, range 0-100 with higher scores indicating better health status

7. Fatigue Questionnaire [6 months]

   11 item, range 0-33 with higher scores implying higher levels of fatigue

8. New biomarkers [6 months]

   Bone marrow fat, serum and urine

9. Micro-RNA, miR-92a [6 months]

   Serum exosomes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway

Sponsors and Collaborators

• Oslo University Hospital
• Hormonlaboratoriet
• Spesialistsenteret Pilestredet Park

Investigators

• Principal Investigator: Erik Fink Eriksen, Professor, Department of Endocrinology, Morbid Obesity and Preventive Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erik Fink Eriksen, Professor, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT03627611
• Other Study ID Numbers: 2017/1883 (REK); 2017-003673-34
• First Posted: Aug 13, 2018
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Erik Fink Eriksen, Professor, Oslo University Hospital: Thyroxine; Triiodothyronine
• Additional relevant MeSH terms: Hypothyroidism; Endocrine System Diseases

Study Results

No Results Posted as of Mar 17, 2021