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
|Condition or disease|
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|
|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|
- 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 ]
- difference in supraclavicular skin temperature (before and after cold exposure) [ Time Frame: before and after 3 months after restoration of euthyroidism ]
- levels of Irisin in serum [ Time Frame: before and after 3 months after restoration of euthyroidism ]
- patient's perception of cold [ Time Frame: before and after 3 months after restoration of euthyroidism ]
Biospecimen Retention: Samples Without DNA
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
|University Hospital Basel, Department of Endocrinology|
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Mirjam Christ-Crain, MD||Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel|