- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03111719
Human Brown Adipose Tissue and Mitochondrial Respiration
February 20, 2020 updated by: Maastricht University Medical Center
Human Brown Adipose Tissue Histological and Mitochondrial Respiratory Analysis
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wouter D Van Marken Lichtenbelt, Professor
- Phone Number: +31(0)433881629
- Email: markenlichtenbelt@maastrichtuniversity.nl
Study Locations
-
-
-
Maastricht, Netherlands
- Recruiting
- Maastricht University Medical Center / University of Maastricht
-
Contact:
- Wouter D Van Marken Lichtenbelt, Professor
- Phone Number: +31(043)3881629
- Email: markenlichten@maastrichtuniversity.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients indicated for surgery in the supraclavicular and neck region
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mitochondrial respiration in human brown
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterise human brown adipose tissue
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nascimento EBM, Moonen MPB, Remie CME, Gariani K, Jorgensen JA, Schaart G, Hoeks J, Auwerx J, van Marken Lichtenbelt WD, Schrauwen P. Nicotinamide Riboside Enhances In Vitro Beta-adrenergic Brown Adipose Tissue Activity in Humans. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1437-1447. doi: 10.1210/clinem/dgaa960.
- Nascimento EBM, Sparks LM, Divoux A, van Gisbergen MW, Broeders EPM, Jorgensen JA, Schaart G, Bouvy ND, van Marken Lichtenbelt WD, Schrauwen P. Genetic Markers of Brown Adipose Tissue Identity and In Vitro Brown Adipose Tissue Activity in Humans. Obesity (Silver Spring). 2018 Jan;26(1):135-140. doi: 10.1002/oby.22062. Epub 2017 Nov 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2010
Primary Completion (Anticipated)
October 10, 2021
Study Completion (Anticipated)
October 10, 2021
Study Registration Dates
First Submitted
March 30, 2017
First Submitted That Met QC Criteria
April 7, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 20, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL31367.068.10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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