Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue

NCT ID: NCT02133040

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-05-10

Brief Summary

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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

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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

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Hyperthyroidism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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T3 > 4 nmol/l

Acute hyperthyroidism with a T3 \> 4 nmol/l

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* men and women with hyperthyroidism (T3 \> 3 nmol/l)
* \> 50 years old
* women must be postmenopausal

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter Breining

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bjørn Richelsen, Professor

Role: STUDY_DIRECTOR

University of Aarhus

Locations

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Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-2013-236-13

Identifier Type: -

Identifier Source: org_study_id

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