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Identification of Non-responders to Levothyroxine Therapy

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ClinicalTrials.gov Identifier: NCT03627611
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Hormonlaboratoriet
Spesialistsenteret Pilestredet Park
Information provided by (Responsible Party):
Erik Fink Eriksen, Oslo University Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : August 14, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: T4 Drug: Levothyroxin
3 months

Experimental: T3 Drug: Liothyronine
3 months




Primary Outcome Measures :
  1. New biomarkers [ Time Frame: 6 months ]
    Bone marrow fat, serum and urine


Secondary Outcome Measures :
  1. Body temperature [ Time Frame: 6 months ]
    Thermography

  2. Metabolism [ Time Frame: 6 months ]
    Indirect calorimetry

  3. Muscle strength [ Time Frame: 6 months ]
    Hand grip test

  4. Patient reported outcome measures [ Time Frame: 6 months ]
    ThyPro-39 Questionnaire

  5. Mean levels of thyroid hormones [ Time Frame: 6 months ]
    TSH, free T4 and free T3



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627611


Contacts
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Contact: Erik Fink Eriksen, Professor +47 92470122 erik.fink.eriksen@medisin.uio.no
Contact: Betty Ann Bjerkreim, MD +47 92269971 Betty.Ann.Bjerkreim@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Erik Fink Eriksen, Professor       e.f.eriksen@medisin.uio.no   
Contact: Betty Ann Bjerkreim, MD       bettyannbn@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
Hormonlaboratoriet
Spesialistsenteret Pilestredet Park
Investigators
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Principal Investigator: Erik Fink Eriksen, Professor Department of Endocrinology, Morbid Obesity and Preventive Medicine

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Responsible Party: Erik Fink Eriksen, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03627611     History of Changes
Other Study ID Numbers: 2017/1883 (REK)
2017-003673-34 ( EudraCT Number )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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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, Oslo University Hospital:
Thyroxine
Triiodothyronine

Additional relevant MeSH terms:
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Hypothyroidism
Endocrine System Diseases
Thyroid Diseases