Effect of Hypothyroidism on Brown Adipose Tissue (NCT02364102) | Clinical Trial Compass
CompletedNot Applicable
Effect of Hypothyroidism on Brown Adipose Tissue
Switzerland42 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: before and after 3 months after restoration of euthyroidism