ObesityNCT01491282
Study of the Effect of Vagus Nerve Stimulation on Human Brown Adipose Tissue Activity
An observational study of Obesity, run by Maastricht University at 1 site in Netherlands.
Trial summary
To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Enabling and disabling VNS
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Nov 2012
- 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: Postoperative patients treated with vagus nerve stimulation for refractory epilepsy
Who may be able to join
- Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2.
Who cannot join
- Body Mass Index > 28 kg/m2
- Daily epileptic insults.
- Subjects that need 'Rapid Cycling' VNS to control their frequency of epileptic insults.
- Psychological unstable subjects (as judged by the treating neurologist).
- subjects with mental retardation (as judged by the treating neurologist).
- subjects with severe behaviour disorders (as judged by the treating neurologist).
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- Pregnant subjects.
- Subjects that previously underwent high dose radiation for diagnostic or therapeutic purposes (radiotherapy, high frequency CT-scans).
- The use of the following medication is an exclusion criterium;
- ß-blockers,
- Ketogenic diet
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, 6200MD
Guy H.E.J. Vijgen, M.D., 0433884252, g.vijgen@maastrichtuniversity.nl
Wouter D. van Marken Lichtenbelt, PhD
About this study
Official title: Brown Adipose Tissue After Vagus Nerve Stimulation
To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.
- Conditions
- Obesity
- Being tested
- Enabling and disabling VNS
- Keywords
- human brown adipose tissue activity, obesity, energy metabolism, adaptive thermogenesis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enabling and disabling VNSOther
Also called VNS
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described Receives: Other: Enabling and disabling VNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
human brown adipose tissue activity
Measured: baseline and 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Sef Janssen, Maastricht University
- Investigators
- Wouter D. van Marken Lichtenbelt, PhD., Principal investigator, Department of Human Biology, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491282
- Sponsor's protocol ID
- MEC 10-3-071
- Status last verified
- Dec 2011
- First submitted
- 30 Nov 2010
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD. Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity. PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221. eCollection 2013.
PubMed 24194874
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue After Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT01491282
- Acronym / sponsor ID
- MEC 10-3-071
- Conditions
- Obesity
- Keywords
- human brown adipose tissue activity, obesity, energy metabolism, adaptive thermogenesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 13 Dec 2011 (estimated)
- 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.
To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: Enabling and disabling VNS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative patients treated with vagus nerve stimulation for refractory epilepsy
Key inclusion criteria (1 listed)
- Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2.
Key exclusion criteria (11 listed)
- Body Mass Index > 28 kg/m2
- Daily epileptic insults.
- Subjects that need 'Rapid Cycling' VNS to control their frequency of epileptic insults.
- Psychological unstable subjects (as judged by the treating neurologist).
- subjects with mental retardation (as judged by the treating neurologist).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enabling and disabling VNSAlso: VNSNo intervention | Other | No treatment |
Primary outcome
human brown adipose tissue activity
Time frame: baseline and 2 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 24194874Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD. Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity. PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221. eCollection 2013.
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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, PhD. principal investigator
Department of Human Biology, Maastricht University
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 Obesity, run by Maastricht University 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 1 inclusion and 11 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 13 Dec 2011. 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 Guy H. Vijgen, M.D. (+31618942736, G.vijgen@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
human brown adipose tissue activity (time frame: baseline and 2 weeks after). 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 NCT01491282, which also lists 1 linked publication.
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 13 Dec 2011.