Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue

September 3, 2018 updated by: Peter Breining, Aarhus University Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
T3 > 4 nmol/l
Acute hyperthyroidism with a T3 > 4 nmol/l

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FDG-PET/CT-scanning
Time Frame: 6 months
Changes in Brown adipose tissue FDG uptake
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indirect Calorimetry
Time Frame: 6 months
Changes in basal energy expenditure
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Changes in adrenergic receptor status and UCP1, PGC1alpha, PRDM16 and Dio2 levels in subcutaneous fat depots
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Novo Nordisk A/S

Investigators

  • Study Director: Bjørn Richelsen, Professor, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

May 10, 2018

Study Completion (ANTICIPATED)

May 10, 2020

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (ESTIMATE)

May 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2013-236-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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