The objective is to study the effect of vagal nerve stimulation on bone turnover, lipid metabolism and inflammation.
ID
Source
Brief title
Condition
- Other condition
- Lipid metabolism disorders
Synonym
Health condition
botmetabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bone turnover: The main outcome parameter is the change of serum concentrations
of bone turnover markers (procollagen type I N propeptide (P1NP) and C-terminal
crosslinking telopeptides of collagen type I (CTX)).
Lipid metabolism: The main outcome parameter is the change of the plasma lipid
profile (cholesterol, LDL, HDL, triglycerides).
Secondary outcome
NA
Background summary
The balance between the sympathetic and parasympathetic autonomic nervous
system controls the activity of almost all organs. Recent experiments indicate
that the autonomic nervous system also controls bone remodeling and lipid
metabolism.
The sympathetic nervous system stimulates bone resorption whereas the
parasympathetic nervous system possibly stimulates bone formation in rodents.
Therefore, stimulation of the vagal nerve could prove an effective way to
increase bone mass as a potential new treatment for osteoporosis.
Recent studies in rodents also show that the autonomic nervous system is
involved in lipid metabolism. Additionally, increased sympathetic and decreased
parasympathetic nerve activity correlates with factors of the metabolic
syndrome, including hypertriglyceridemia in a large cohort of patients.
Conversely, in the normal population high parasympathetic nervous activity
correlates with a low BMI. This could indicate a beneficiary effect of vagal
nerve stimulation on the plasma lipid profile.
Study objective
The objective is to study the effect of vagal nerve stimulation on bone
turnover, lipid metabolism and inflammation.
Study design
Prospective, longitudinal cohort study.
Study burden and risks
Patients undergo venous blood sampling at five different time points. The risks
of venous blood sampling are negligible and the total amount of blood drawn
will not exceed 125 ml in total (during 5 blooddraws).
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients eligible for vagal nerve stimulator implantation
Age >18 years
Exclusion criteria
Incapability of giving informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39889.018.12 |