Faced with the current obesity epidemic, new avenues of research into effective weight loss must be developed. Among the possible actions on obesity, vagus nerve stimulation has been shown in several studies to be effective in treating epilepsy or depression, at the same time inducing weight loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss in experimental animal studies. Vagus nerve stimulation has never been attempted in obese patients awaiting bariatric surgery.
The primary objective is to demonstrate the benefit of transcutaneous vagus nerve stimulation in obese subjects awaiting surgery. Secondary objectives include, among others, the risk factors related to obesity, systemic micro-inflammation, insulin and lipid profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum. For this intervention, the stimulations are active.
A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum. For this intervention, the stimulations are inactive.
CHU de Saint-Etienne
Saint-Etienne, France
Weight
the weight (kg) is measured after 6 months of noninvasive stimulation.
Time frame: at 6 months
Heart rate variability (HRV)
HRV is measured by a 24H-Holter Electrocardiography (ECG). It is a composite outcome : * the standard deviation of NN intervals (SDNN) * the proportion of number of pairs of successive NNs that differ by more than 50 ms, divided by total number of NNs (pNN50) * high frequency (HF) * low frequency (LF) * very low frequency (VLF)
Time frame: at 3, 6, 9 and 12 months
Systemic inflammation
Markers of systemic inflammation will be measured on centrifuged serum for C-reactive protein (CRP) and by immuno microassay using the Luminex method for InterLeukin (IL)-6 and IL-17.
Time frame: at 3, 6, 9 and 12 months
Apnea-hypopnea index (AHI)
AHI is analyzed by a polysomnography in an outpatient setting.
Time frame: at 3, 6, 9 and 12 months
Patient Health Questionnaire-9 (PHQ-9)
It is a anxiety scale
Time frame: at 3, 6, 9 and 12 months
Blood pressure
Time frame: at 1, 3, 6, 9 and 12 months
Octanoylated ghrelin hormone
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Glucagon-like peptide-1 hormone (GLP1)
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Peptide tyrosine tyrosine hormone (PYY)
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Serum insulin level
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Glycemia
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Glycated hemoglobin
Patients will be subjected to blood samplings
Time frame: at 3, 6, 9 and 12 months
Adverse effects
Local and systemic adverse effects will be described at each consultation. In particular, patients will be informed that they can call the investigator if they have any questions or to report any effects that seem unusual.
Time frame: at 12 months
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