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

Obesity Clinical Trial

Official title:

Brown Adipose Tissue After Vagus Nerve Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01491282
• Other study ID #: MEC 10-3-071
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2010
• Last updated: December 11, 2011
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2011
• Source: Maastricht University
• Contact: Guy H. Vijgen, M.D.
• Phone: +31618942736
• Email: G.vijgen[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Enabling and disabling VNS
No intervention

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	human brown adipose tissue activity		baseline and 2 weeks after	No