Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery
- Conditions
- ObesityBariatric Surgery
- Interventions
- Device: NeuroCoach II Stim
- Registration Number
- NCT02648191
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
- Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40
- Consent Form signed
- Permanent atrial fibrillation
- Patient on treatment that could influence measurement of Autonomic Nervus System (ANS) activity (eg. anti-arrhythmics).
- For patients previously operated (by any technique), an interval of at least 6 months since the surgery must be observed
- Pacemaker
- Serious cardiac pathology
- History of myocardial infarction
- History of Stroke
- Severe respiratory insufficiency
- Allergy in the Rhodium and in the gold
- Surgery of the vagus nerve
- Pregnant patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inactive stimulation NeuroCoach II Stim - Active stimulation NeuroCoach II Stim -
- Primary Outcome Measures
Name Time Method Weight at 6 months the weight (kg) is measured after 6 months of noninvasive stimulation.
- Secondary Outcome Measures
Name Time Method Blood pressure at 1, 3, 6, 9 and 12 months Glucagon-like peptide-1 hormone (GLP1) at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Glycated hemoglobin at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Adverse effects at 12 months 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.
Peptide tyrosine tyrosine hormone (PYY) at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Apnea-hypopnea index (AHI) at 3, 6, 9 and 12 months AHI is analyzed by a polysomnography in an outpatient setting.
Systemic inflammation at 3, 6, 9 and 12 months 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.
Patient Health Questionnaire-9 (PHQ-9) at 3, 6, 9 and 12 months It is a anxiety scale
Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride) at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Heart rate variability (HRV) at 3, 6, 9 and 12 months 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)Octanoylated ghrelin hormone at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Serum insulin level at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Glycemia at 3, 6, 9 and 12 months Patients will be subjected to blood samplings
Trial Locations
- Locations (1)
CHU de Saint-Etienne
🇫🇷St Etienne, France