Clinical trial NCT02648191: Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery
Official title: Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Bariatric Surgery
Keywords: Obesity
Bariatric Surgery
No invasive intra-auricular vagus nerve stimulation
Weight loss
Autonomic nervous system
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2016-01-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40
* Consent Form signed

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weight
timeFrame: at 6 months
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: at 3, 6, 9 and 12 months
measure: Systemic inflammation
timeFrame: at 3, 6, 9 and 12 months
measure: Apnea-hypopnea index (AHI)
timeFrame: at 3, 6, 9 and 12 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: at 3, 6, 9 and 12 months
measure: Blood pressure
timeFrame: at 1, 3, 6, 9 and 12 months
measure: Octanoylated ghrelin hormone
timeFrame: at 3, 6, 9 and 12 months
measure: Glucagon-like peptide-1 hormone (GLP1)
timeFrame: at 3, 6, 9 and 12 months
measure: Peptide tyrosine tyrosine hormone (PYY)
timeFrame: at 3, 6, 9 and 12 months
measure: Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)
timeFrame: at 3, 6, 9 and 12 months
measure: Serum insulin level
timeFrame: at 3, 6, 9 and 12 months
measure: Glycemia
timeFrame: at 3, 6, 9 and 12 months
measure: Glycated hemoglobin
timeFrame: at 3, 6, 9 and 12 months
measure: Adverse effects
timeFrame: at 12 months
Other outcomes:
Locations:
city: St Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de St Etienne
name: Radwan KASSIR, MD
role: PRINCIPAL_INVESTIGATOR
References: