Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue

Hyperthyroidism Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02133040
• Other study ID #: M-2013-236-13
• Status: Active, not recruiting
• Start date: May 2014
• Est. completion date: May 10, 2020

Study information

• Verified date: September 2018
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 euthyroid phase after treatment.

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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 ß-blockers

• severe claustrophobia

• BMI > 30 kg/m2

Related Conditions & MeSH terms

• Hyperthyroidism

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in adrenergic receptor status and UCP1, PGC1alpha, PRDM16 and Dio2 levels in subcutaneous fat depots		6 months
Primary	FDG-PET/CT-scanning	Changes in Brown adipose tissue FDG uptake	6 months
Secondary	Indirect Calorimetry	Changes in basal energy expenditure	6 months