Does bilateral deep brain stimulation of the subthalamic nucleus in patients with Parkinson's disease influence plasma triglycerides and glucose metabolism?
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of the effect of stimulation on the subthalamic nucleus on plasma
triglycerides and glucose metabolism.
Secondary outcome
NA
Background summary
Observations showed involvement of the hypothalamus in glucose-, and
triglycerides metabolism. Patients with a deep brain stimulator might also have
a change in the glucose metabolism and plasma triglycerides due to the deep
brain stimulator. With this study we would like to get more insight in the
influence of the metabolism of patients with a deep brain stimulator of the
subthalamic nucleus.
Study objective
Does bilateral deep brain stimulation of the subthalamic nucleus in patients
with Parkinson's disease influence plasma triglycerides and glucose metabolism?
Study design
An observational cohort study with inclusion of 10 patients, visiting 5 times.
Study burden and risks
Labelled glucose behaves in vivo as unlabeled glucose and therefore has no side
effects.
Labelled water may cause some dizziness, for that reason patients consume this
in 5 equal portions with an interval of 30 minutes.
During the 2 visits of evaluation 250 ml of blood will be withdrawn per visit.
At the insertion of the venous cannula, a hematoma may occuur.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with idiopathic Parkinson's disease, bilateral subthalamic nucleus deep brain stimulation, and a documented effect of bilateral subthalamic nucleus deep brain stimulation on parkinsonism *measured with the Unified Parkinson*s disease Rating Scale (UPDRS) motor section*equal or more than 75% of the difference between the preoperative provoked OFF and ON phases.
Exclusion criteria
Age less than 18 years, other functional stereotactic neurosurgical interventions (e.g. pallidotomy), psychosis, depression, alcoholism, dyslipidemia (primary or secondary form), use of lipid lowering drugs, unstable weight, presence of type II diabetes mellitus, former history of diabetes gravidarum, first line familial preponderance of type II diabetes mellitus, active smoking, renal insufficiency (creatinine > 150 umol/L, creatinine clearance <60 ml/min) or elevated liver enzymes (2x upper limit).
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 | NL22171.018.08 |