NCT03111719

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2010

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

11.8 years

First QC Date

March 30, 2017

Last Update Submit

February 20, 2020

Conditions

Mitochondrial Metabolism DisordersAdipose Tissue, BrownAgingObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Characterise human brown adipose tissue

    8 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients indicated for surgery in the supraclavicular and neck region

You may qualify if:

  • 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

You may not qualify if:

  • Pre-operatively diagnosed malign tumour
  • Patients undergoing acute surgery because of critical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center / University of Maastricht

Maastricht, Netherlands

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33524145DERIVED

  • 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.

    PMID: 29178600DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wouter D Van Marken Lichtenbelt, Professor

CONTACT

+31(0)433881629markenlichtenbelt@maastrichtuniversity.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 13, 2017

Study Start

January 4, 2010

Primary Completion

October 10, 2021

Study Completion

October 10, 2021

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

NL(1)