Study of the Effect of Vagus Nerve Stimulation on Human Brown Adipose Tissue Activity

NCT ID: NCT01491282

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-11-30

Brief Summary

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To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.

Detailed Description

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Conditions

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Obesity

Keywords

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human brown adipose tissue activity obesity energy metabolism adaptive thermogenesis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

Enabling and disabling VNS

Intervention Type OTHER

No intervention

Interventions

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Enabling and disabling VNS

No intervention

Intervention Type OTHER

Other Intervention Names

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VNS

Eligibility Criteria

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Inclusion Criteria

* Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2.

Exclusion Criteria

* 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).
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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dr. Sef Janssen

Dr. W.D. van Marken Lichtenbelt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wouter D. van Marken Lichtenbelt, PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Human Biology, Maastricht University

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Guy H. Vijgen, M.D.

Role: CONTACT

Phone: +31618942736

Email: [email protected]

Wouter D. van Marken Lichtenbelt, PhD.

Role: CONTACT

Phone: +31433881629

Email: [email protected]

Facility Contacts

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Guy H.E.J. Vijgen, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 24194874 (View on PubMed)

Other Identifiers

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MEC 10-3-071

Identifier Type: -

Identifier Source: org_study_id