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Effect of Hypothyroidism on Brown Adipose Tissue

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT02364102
Collaborator
(none)
42
Enrollment
1
Location
28
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to study whether hypothyroidism negatively affects Brown adipose tissue (BAT) function in humans and whether BAT function can be restored to normal by thyroid hormone supplementation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypothyroidism is a frequent endocrine disorder, the prevalence of subclinical disease being 4.3% and of overt disease being 0.3%. Patients suffering from hypothyroidism frequently complain of increased cold sensitivity and involuntary weight gain, indicating changes in energy expenditure and response to cold challenge.

    Recently, brown adipose tissue (BAT) has regained attention as an energy expending tissue. While it was previously thought to be of no or negligible relevance in human adults, recent studies clearly demonstrated the presence and metabolic activity of BAT in human adults. Upon activation of BAT by the sympathetic nervous system intracellular lipid stores are rapidly depleted. The generated free fatty acids fuel beta-oxidation and the respiratory chain within the mitochondria and activate at the same time uncoupling protein 1 (UCP1). This protein acts as a protonophore, allowing the flux of protons along the electrochemical gradient into the inner mitochondrial matrix instead of transferring their energy to adenosine triphosphate (ATP)-synthase. The short circuiting of the oxidative phosphorylation within the mitochondria leads to highly active cellular respiration and generation of heat. Basic research highlights the importance of thyroid hormone in the development and function of BAT.

    It has recently been shown that hyperthyroidism exerts activating effects on BAT in adult humans.

    The investigators aim to study whether hypothyroidism negatively affects BAT function in humans and whether BAT function can be restored to normal by thyroid hormone supplementation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    42 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Restoration of Euthyroidism in Patients With Primary Hypothyroidism on Brown Adipose Tissue Thermogenesis - the ThyroBAT Study
    Actual Study Start Date :
    Apr 1, 2015
    Actual Primary Completion Date :
    Aug 1, 2017
    Actual Study Completion Date :
    Aug 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. difference in cold induced thermogenesis between baseline and restoration of euthyroidism, assessed as the increase in resting energy expenditure after a mild cold stimulus determined by indirect calorimetry [before and after 3 months after restoration of euthyroidism]

    Secondary Outcome Measures

    1. difference in supraclavicular skin temperature (before and after cold exposure) [before and after 3 months after restoration of euthyroidism]

    2. levels of Irisin in serum [before and after 3 months after restoration of euthyroidism]

    3. patient's perception of cold [before and after 3 months after restoration of euthyroidism]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • informed consent

    • Serum thyroid-stimulating hormone (TSH) > 4.5 milli-International unit (mIU)/l

    • body mass index (weight/height(m)²) 17.5 to 30 kg/m²

    Exclusion Criteria:

    • known concomitant disease influencing thyroid hormone metabolism

    • chronic heart failure

    • liver cirrhosis

    • severe kidney failure

    • metastasized cancer, except for thyroid cancer

    • known hypersensitivity to cold, e.g. primary or secondary Raynaud's syndrome

    • abuse of alcohol or illicit drugs

    • Women who are pregnant or breast feeding

    • Intention to become pregnant during the course of the study

    • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

    • Participation in another study with investigational drug within the 30 days preceding and during the present study

    • Previous enrolment into the current study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel, Department of Endocrinology Basel BS Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Mirjam Christ-Crain, MD, Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT02364102
    Other Study ID Numbers:
    • EKNZ 2015-028
    First Posted:
    Feb 16, 2015
    Last Update Posted:
    Aug 28, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Hypothyroidism

    Study Results

    No Results Posted as of Aug 28, 2017