Identification of Non-responders to Levothyroxine Therapy

March 12, 2021 updated by: Erik Fink Eriksen, Oslo University Hospital

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: T4
3 months
Experimental: T3
3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brown adipose tissue activation
Time Frame: 6 months
Thermal imaging of supraclavicular fossa
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Actual)

June 22, 2020

Study Completion (Actual)

June 22, 2020

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/1883 (REK)
  • 2017-003673-34 (EudraCT Number)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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