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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by dr. Sef Janssen, Maastricht University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491282
First Posted: December 13, 2011
Last Update Posted: December 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
dr. Sef Janssen, Maastricht University
  Purpose
To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.

Condition Intervention
Obesity Other: Enabling and disabling VNS

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Brown Adipose Tissue After Vagus Nerve Stimulation

Further study details as provided by dr. Sef Janssen, Maastricht University:

Primary Outcome Measures:
  • human brown adipose tissue activity [ Time Frame: baseline and 2 weeks after ]

Estimated Enrollment: 5
Study Start Date: January 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment Other: Enabling and disabling VNS
No intervention
Other Name: VNS

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postoperative patients treated with vagus nerve stimulation for refractory epilepsy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491282


Contacts
Contact: Guy H. Vijgen, M.D. +31618942736 G.vijgen@maastrichtuniversity.nl
Contact: Wouter D. van Marken Lichtenbelt, PhD. +31433881629 markenlichtenbelt@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Netherlands, 6200MD
Contact: Guy H.E.J. Vijgen, M.D.    0433884252    g.vijgen@maastrichtuniversity.nl   
Principal Investigator: Wouter D. van Marken Lichtenbelt, PhD         
Sponsors and Collaborators
Maastricht University
Investigators
Principal Investigator: Wouter D. van Marken Lichtenbelt, PhD. Department of Human Biology, Maastricht University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr. Sef Janssen, Dr. W.D. van Marken Lichtenbelt, Maastricht University
ClinicalTrials.gov Identifier: NCT01491282     History of Changes
Other Study ID Numbers: MEC 10-3-071
First Submitted: November 30, 2010
First Posted: December 13, 2011
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by dr. Sef Janssen, Maastricht University:
human brown adipose tissue activity
obesity
energy metabolism
adaptive thermogenesis