Mitochondrial Metabolism DisordersNCT03111719
Human Brown Adipose Tissue and Mitochondrial Respiration
An observational study of Mitochondrial Metabolism Disorders and Adipose Tissue, Brown, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mitochondrial Metabolism Disorders, Adipose Tissue, Brown, Aging
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jan 2010to 10 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for surgery in the supraclavicular and neck region
Who may be able to join
- 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
Who cannot join
- Pre-operatively diagnosed malign tumour
- Patients undergoing acute surgery because of critical illness
Trial locations and contacts
1 site in 1 country.
Wouter D Van Marken Lichtenbelt, Professor contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center / University of Maastricht
Maastricht
Wouter D Van Marken Lichtenbelt, Professor, +31(043)3881629, markenlichten@maastrichtuniversity.nl
About this study
Official title: 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.
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start4 Jan 2010
- Primary completion10 Oct 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Culture and Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111719
- Sponsor's protocol ID
- NL31367.068.10
- Status last verified
- Feb 2020
- First submitted
- 30 Mar 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
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.
PubMed 33524145Nascimento 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.
PubMed 29178600
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Brown Adipose Tissue Histological and Mitochondrial Respiratory Analysis
- ClinicalTrials.gov ID
- NCT03111719
- Acronym / sponsor ID
- NL31367.068.10
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Education, Culture and Science
- Study start
- 4 Jan 2010 (actual)
- Primary completion
- 10 Oct 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for surgery in the supraclavicular and neck region
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pre-operatively diagnosed malign tumour
- Patients undergoing acute surgery because of critical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Characterise human brown adipose tissue
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 33524145Nascimento 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.
- Derived from this study: PubMed 29178600Nascimento 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter D Van Marken Lichtenbelt, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial Metabolism Disorders and Adipose Tissue, Brown, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wouter D Van Marken Lichtenbelt, Professor (+31(0)433881629, markenlichtenbelt@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial respiration in human brown (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.