Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue

Sponsor

Aarhus University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02133040

Collaborator

Novo Nordisk A/S (Industry)

Enrollment

Location

72.3

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperthyroidism

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

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 10, 2018

Anticipated Study Completion Date :

May 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
T3 > 4 nmol/l Acute hyperthyroidism with a T3 > 4 nmol/l

Outcome Measures

Primary Outcome Measures

FDG-PET/CT-scanning [6 months]
Changes in Brown adipose tissue FDG uptake

Secondary Outcome Measures

Indirect Calorimetry [6 months]
Changes in basal energy expenditure

Other Outcome Measures

Changes in adrenergic receptor status and UCP1, PGC1alpha, PRDM16 and Dio2 levels in subcutaneous fat depots [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus	Region Midtjylland	Denmark	8000

Sponsors and Collaborators

Aarhus University Hospital
Novo Nordisk A/S

Investigators

Study Director: Bjørn Richelsen, Professor, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Breining, MD, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT02133040

Other Study ID Numbers:

M-2013-236-13

First Posted:

May 7, 2014

Last Update Posted:

Sep 5, 2018

Last Verified:

Sep 1, 2018

Keywords provided by Peter Breining, MD, Aarhus University Hospital

Brown Adipose Tissue

Additional relevant MeSH terms:

Hyperthyroidism

Study Results

No Results Posted as of Sep 5, 2018