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Effect of Hypothyroidism on Brown Adipose Tissue

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ClinicalTrials.gov Identifier: NCT02364102
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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
Hypothyroidism

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 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 : April 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism
U.S. FDA Resources




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 [ Time Frame: before and after 3 months after restoration of euthyroidism ]

Secondary Outcome Measures :
  1. difference in supraclavicular skin temperature (before and after cold exposure) [ Time Frame: before and after 3 months after restoration of euthyroidism ]
  2. levels of Irisin in serum [ Time Frame: before and after 3 months after restoration of euthyroidism ]
  3. patient's perception of cold [ Time Frame: before and after 3 months after restoration of euthyroidism ]

Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
currently hypothyroid patients which are started on levothyroxin substitution
Criteria

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

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): NCT02364102


Locations
Switzerland
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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02364102     History of Changes
Other Study ID Numbers: EKNZ 2015-028
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases