Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery

Obesity Clinical Trial

— OBESITE  

Official title:

Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02648191
• Other study ID #: 1508013
• Secondary ID: 2015-A00253-46
• Status: Terminated
• Phase: N/A
• Start date: March 2, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Intervention

Device:
• NeuroCoach II Stim
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.
• NeuroCoach II Stim
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.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	St Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	the weight (kg) is measured after 6 months of noninvasive stimulation.	at 6 months
Secondary	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)	at 3, 6, 9 and 12 months
Secondary	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.	at 3, 6, 9 and 12 months
Secondary	Apnea-hypopnea index (AHI)	AHI is analyzed by a polysomnography in an outpatient setting.	at 3, 6, 9 and 12 months
Secondary	Patient Health Questionnaire-9 (PHQ-9)	It is a anxiety scale	at 3, 6, 9 and 12 months
Secondary	Blood pressure		at 1, 3, 6, 9 and 12 months
Secondary	Octanoylated ghrelin hormone	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	Glucagon-like peptide-1 hormone (GLP1)	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	Peptide tyrosine tyrosine hormone (PYY)	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	Serum insulin level	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	Glycemia	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	Glycated hemoglobin	Patients will be subjected to blood samplings	at 3, 6, 9 and 12 months
Secondary	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.	at 12 months