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Identification of Non-responders to Levothyroxine Therapy

Primary Purpose

Hypothyroidism, Biomarkers, Endocrine System Diseases

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Levothyroxin
Liothyronine
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothyroidism focused on measuring Thyroxine, Triiodothyronine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

T4

T3

Arm Description

Outcomes

Primary Outcome Measures

Brown adipose tissue activation
Thermal imaging of supraclavicular fossa

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2018
Last Updated
March 12, 2021
Sponsor
Oslo University Hospital
Collaborators
Hormonlaboratoriet, Spesialistsenteret Pilestredet Park
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1. Study Identification

Unique Protocol Identification Number
NCT03627611
Brief Title
Identification of Non-responders to Levothyroxine Therapy
Official Title
A Randomized Crossover Study, Examining Differential Effects of Levothyroxine and Liothyronine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
June 22, 2020 (Actual)
Study Completion Date
June 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Hormonlaboratoriet, Spesialistsenteret Pilestredet Park

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Biomarkers, Endocrine System Diseases
Keywords
Thyroxine, Triiodothyronine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Fink Eriksen, Professor
Organizational Affiliation
Department of Endocrinology, Morbid Obesity and Preventive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35572853
Citation
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.
Results Reference
derived
PubMed Identifier
35273566
Citation
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.
Results Reference
derived
PubMed Identifier
34867829
Citation
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.
Results Reference
derived

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Identification of Non-responders to Levothyroxine Therapy

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