Effect of Hypothyroidism on Brown Adipose Tissue
Effect of Restoration of Euthyroidism in Patients With Primary Hypothyroidism on Brown Adipose Tissue Thermogenesis - the ThyroBAT Study
1 other identifier
observational
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 16, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 28, 2017
August 1, 2017
2.3 years
February 9, 2015
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (3)
difference in supraclavicular skin temperature (before and after cold exposure)
before and after 3 months after restoration of euthyroidism
levels of Irisin in serum
before and after 3 months after restoration of euthyroidism
patient's perception of cold
before and after 3 months after restoration of euthyroidism
Eligibility Criteria
currently hypothyroid patients which are started on levothyroxin substitution
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031, Switzerland
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirjam Christ-Crain, MD
Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 16, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 28, 2017
Record last verified: 2017-08