Effect of Hypothyroidism on Brown Adipose Tissue

NCT ID: NCT02364102

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-08-31

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.

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.

Conditions

Hypothyroidism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirjam Christ-Crain, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel

Locations

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

EKNZ 2015-028

Identifier Type: -

Identifier Source: org_study_id