Brown adipose tissue after vagus nerve stimulatio
- Conditions
- brown fatobesity10003018
- Registration Number
- NL-OMON38162
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Subjects treated with Vagus Nerve Stimulation (VNS) for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) <= 28 kg/m2. Patients need to have optimally adjusted, stable VNS as judged by the treating neurologist.
• Body Mass Index > 28 kg/m2
• Daily epileptic insults.
• Subjects that need or needed *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;
o ß-blockers,
o Ketogenic diet
• Subjects that recieved high doses of ionising radiation (x-ray or gamma radiation) in their medical history will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of this study is BAT activity in kBq after active VNS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the effect of VNS on energy expenditure, body core<br /><br>temperature, skin surface temperature, skin perfusion and food intake.<br /><br><br /><br>Other study parameters<br /><br><br /><br>Other relevant study parameters are medical history, medication, current<br /><br>medical status, age, body weight, weight history, height, sex, thyroid gland<br /><br>function, and UCP-1 and beta3-receptor polymorphisms.</p><br>