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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03111719
Other study ID # NL31367.068.10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2010
Est. completion date October 10, 2021

Study information

Verified date February 2020
Source Maastricht University Medical Center
Contact Wouter D Van Marken Lichtenbelt, Professor
Phone +31(0)433881629
Email markenlichtenbelt@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is focused on measuring mitochondrial activity of human brown adipose tissue. During surgery, adipose tissue biopsies from white and brown adipose tissue will be collected from the deep neck area. These biopsies will be used to examine mitochondrial function via histological analysis, biochemical analysis and in vitro experiments based on precursor cells present in the biopsies.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date October 10, 2021
Est. primary completion date October 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Indication for surgery in the supraclavicular and neck region (more specific patients diagnosed with hyperparathyroidism, struma, benign thyroid gland tumours, implantation of a vagal neurostimulator for epilepsia and cervical neurologic disorders)

- In the thyroid gland group, euthyroid function

Exclusion Criteria:

- Pre-operatively diagnosed malign tumour

- Patients undergoing acute surgery because of critical illness

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Maastricht University Medical Center / University of Maastricht Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Ministry of Education, Culture and Science

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mitochondrial respiration in human brown Measure of mitochondrial respiration in human brown adipose tissue biopsies and measure mitochondrial respiration in cells derived from human brown adipose tissue biopsies. With high resolution respirometry , oxygen consumption in mitochondria will be determined using different substrates that stimulate mitochondrial activity including norepinephrine which is a natural agonist to increase mitochondrial activity in brown adipose tissue. During these experiments mitochondrial complex activity can be inhibited using specific inhibitors. 8 weeks
Secondary Characterise human brown adipose tissue Perform histological analysis and biochemical analysis in brown adipose tissue biopsies and compare to skeletal muscle. Via qPCR analysis, western blotting and immunfluorescence we will examine UCP1 expression in BAT. 8 weeks
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