HyperthyroidismNCT02133040
Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue
An observational study of Hyperthyroidism, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in humans in an observational study on patients with thyrotoxicosis. In the investigators evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in the acute phase of the disease and in the… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hyperthyroidism
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to 10 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients with hyperthyroidism, reffered to our hospital from their primary caretakers will be investigated before and after 3 to 5 months in a proven euthyroid state.
Who may be able to join
- men and women with hyperthyroidism (T3 > 3 nmol/l)
- > 50 years old
- women must be postmenopausal
Who cannot join
- thyrotoxic crises
- severe concurrent sickness that will make it unsafe to postpone treatment, this includes severe kidney disease (creatinin over 160)- and heart disease (NYHA group 3 and 4).
- diabetes
- former and current treatment with interleukin-2
- Patients who are already treated with β-blockers
- severe claustrophobia
- BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Regulation of Brown Adipose Tissue (BAT) in Humans. Implications for Energy Expenditure in Humans and in the Treatment of Obesity and Related Metabolic Diseases
The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in humans in an observational study on patients with thyrotoxicosis. In the investigators evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in the acute phase of the disease and in the euthyroid phase after treatment.
It is the investigators hypothesis that high levels of circulating T3 might affect amount and function of brown adipose tissue.
Read the detailed description
10 patients with thyreotoxicosis (T3 > 3 nmol/L and suppressed TSH) will be investigated at diagnosis and after 3-6 months of euthyroidism induced by antithyroid treatment. The patients will all be over the age of 50 due to the radiation given by the scans (requested by the local Ethical Committee). All will be scanned for active BAT by the integrated FDG PET-CT before and after treatment.BAT is activated by means of crushed ice placed under the feet in individualized intervals during the scan procedure. Indirect calorimetry is done to determine the basal metabolic rate and subcutaneous fat biopsy to examine the effect on subcutaneous white fat and the possible "browning" effect.
- Conditions
- Hyperthyroidism
- Keywords
- Brown Adipose Tissue
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T3 > 4 nmol/l | Acute hyperthyroidism with a T3 > 4 nmol/l |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG-PET/CT-scanning
Changes in Brown adipose tissue FDG uptake
Measured: 6 months
Secondary outcomes (1)
Indirect Calorimetry
Changes in basal energy expenditure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completion10 May 2018
- Study completion10 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Peter Breining, Aarhus University Hospital
- Investigators
- Bjørn Richelsen, Professor, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133040
- Sponsor's protocol ID
- M-2013-236-13
- Status last verified
- Sep 2018
- First submitted
- 5 May 2014
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Regulation of Brown Adipose Tissue (BAT) in Humans. Implications for Energy Expenditure in Humans and in the Treatment of Obesity and Related Metabolic Diseases
- ClinicalTrials.gov ID
- NCT02133040
- Acronym / sponsor ID
- M-2013-236-13
- Conditions
- Hyperthyroidism
- Keywords
- Brown Adipose Tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- May 2014 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2020 (estimated)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in humans in an observational study on patients with thyrotoxicosis. In the investigators evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in the acute phase of the disease and in the euthyroid phase after treatment.
It is the investigators hypothesis that high levels of circulating T3 might affect amount and function of brown adipose tissue.
Detailed description
10 patients with thyreotoxicosis (T3 > 3 nmol/L and suppressed TSH) will be investigated at diagnosis and after 3-6 months of euthyroidism induced by antithyroid treatment. The patients will all be over the age of 50 due to the radiation given by the scans (requested by the local Ethical Committee). All will be scanned for active BAT by the integrated FDG PET-CT before and after treatment.BAT is activated by means of crushed ice placed under the feet in individualized intervals during the scan procedure. Indirect calorimetry is done to determine the basal metabolic rate and subcutaneous fat biopsy to examine the effect on subcutaneous white fat and the possible "browning" effect.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T3 > 4 nmol/l | – | –Acute hyperthyroidism with a T3 > 4 nmol/l |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with hyperthyroidism, reffered to our hospital from their primary caretakers will be investigated before and after 3 to 5 months in a proven euthyroid state.
Key inclusion criteria (3 listed)
- men and women with hyperthyroidism (T3 > 3 nmol/l)
- > 50 years old
- women must be postmenopausal
Key exclusion criteria (7 listed)
- thyrotoxic crises
- severe concurrent sickness that will make it unsafe to postpone treatment, this includes severe kidney disease (creatinin over 160)- and heart disease (NYHA group 3 and 4).
- diabetes
- former and current treatment with interleukin-2
- Patients who are already treated with β-blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FDG-PET/CT-scanning
Time frame: 6 months
Changes in Brown adipose tissue FDG uptake
1 secondary outcome
Indirect Calorimetry
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Richelsen, Professor study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDG-PET/CT-scanning (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.