NCT02133040

Brief 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 euthyroid phase after treatment. It is the investigators hypothesis that high levels of circulating T3 might affect amount and function of brown adipose tissue.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

May 5, 2014

Last Update Submit

September 3, 2018

Conditions

Hyperthyroidism

Keywords

Brown Adipose Tissue

Outcome Measures

Primary Outcomes (1)

  • FDG-PET/CT-scanning

    Changes in Brown adipose tissue FDG uptake

    6 months

Secondary Outcomes (1)

  • Indirect Calorimetry

    6 months

Other Outcomes (1)

  • Changes in adrenergic receptor status and UCP1, PGC1alpha, PRDM16 and Dio2 levels in subcutaneous fat depots

    6 months

Study Arms (1)

T3 > 4 nmol/l

Acute hyperthyroidism with a T3 \> 4 nmol/l

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and fat tissue

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Bjørn Richelsen, Professor

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

May 1, 2014

Primary Completion

May 10, 2018

Study Completion

May 10, 2020

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

DK(1)