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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02364102
Date of registration:	09/02/2015
Prospective Registration:	Yes
Primary sponsor:	University Hospital, Basel, Switzerland
Public title:	Effect of Hypothyroidism on Brown Adipose Tissue
Scientific title:	Effect of Restoration of Euthyroidism in Patients With Primary Hypothyroidism on Brown Adipose Tissue Thermogenesis - the ThyroBAT Study
Date of first enrolment:	April 2015
Target sample size:	42
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02364102
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Switzerland

Contacts

Name:	Mirjam Christ-Crain, MD
Address:
Telephone:
Email:
Affiliation:	Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel

Key inclusion & exclusion criteria

Inclusion Criteria:

- informed consent

- Serum thyroid-stimulating hormone (TSH) > 4.5 milli-International unit (mIU)/l

- body mass index (weight/height(m)²) 17.5 to 30 kg/m²

Exclusion Criteria:

- known concomitant disease influencing thyroid hormone metabolism

- chronic heart failure

- liver cirrhosis

- severe kidney failure

- metastasized cancer, except for thyroid cancer

- known hypersensitivity to cold, e.g. primary or secondary Raynaud's syndrome

- abuse of alcohol or illicit drugs

- Women who are pregnant or breast feeding

- Intention to become pregnant during the course of the study

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant

- Participation in another study with investigational drug within the 30 days preceding
and during the present study

- Previous enrolment into the current study

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypothyroidism

Intervention(s)

Primary Outcome(s)

difference in cold induced thermogenesis between baseline and restoration of euthyroidism, assessed as the increase in resting energy expenditure after a mild cold stimulus determined by indirect calorimetry [Time Frame: before and after 3 months after restoration of euthyroidism]

Secondary Outcome(s)

levels of Irisin in serum [Time Frame: before and after 3 months after restoration of euthyroidism]

difference in supraclavicular skin temperature (before and after cold exposure) [Time Frame: before and after 3 months after restoration of euthyroidism]

patient's perception of cold [Time Frame: before and after 3 months after restoration of euthyroidism]

Secondary ID(s)

EKNZ 2015-028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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