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

Primary Purpose

Obesity, Bariatric Surgery

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NeuroCoach II Stim
NeuroCoach II Stim
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric Surgery, No invasive intra-auricular vagus nerve stimulation, Weight loss, Autonomic nervous system

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation

Inactive stimulation

Arm Description

Outcomes

Primary Outcome Measures

Weight
the weight (kg) is measured after 6 months of noninvasive stimulation.

Secondary Outcome Measures

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)
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.
Apnea-hypopnea index (AHI)
AHI is analyzed by a polysomnography in an outpatient setting.
Patient Health Questionnaire-9 (PHQ-9)
It is a anxiety scale
Blood pressure
Octanoylated ghrelin hormone
Patients will be subjected to blood samplings
Glucagon-like peptide-1 hormone (GLP1)
Patients will be subjected to blood samplings
Peptide tyrosine tyrosine hormone (PYY)
Patients will be subjected to blood samplings
Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)
Patients will be subjected to blood samplings
Serum insulin level
Patients will be subjected to blood samplings
Glycemia
Patients will be subjected to blood samplings
Glycated hemoglobin
Patients will be subjected to blood samplings
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.

Full Information

First Posted
January 5, 2016
Last Updated
July 17, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT02648191
Brief Title
Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery
Acronym
OBESITE
Official Title
Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of inclusion and departure of the investigator
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Fondation de l'Avenir

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery
Keywords
Obesity, Bariatric Surgery, No invasive intra-auricular vagus nerve stimulation, Weight loss, Autonomic nervous system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation
Arm Type
Experimental
Arm Title
Inactive stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
NeuroCoach II Stim
Other Intervention Name(s)
NeuroCoach II Stim, NBA Techno, France
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NeuroCoach II Stim
Other Intervention Name(s)
NeuroCoach II Stim, NBA Techno, France
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
the weight (kg) is measured after 6 months of noninvasive stimulation.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Heart rate variability (HRV)
Description
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
Title
Systemic inflammation
Description
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
Title
Apnea-hypopnea index (AHI)
Description
AHI is analyzed by a polysomnography in an outpatient setting.
Time Frame
at 3, 6, 9 and 12 months
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
It is a anxiety scale
Time Frame
at 3, 6, 9 and 12 months
Title
Blood pressure
Time Frame
at 1, 3, 6, 9 and 12 months
Title
Octanoylated ghrelin hormone
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Glucagon-like peptide-1 hormone (GLP1)
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Peptide tyrosine tyrosine hormone (PYY)
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Serum insulin level
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Glycemia
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Glycated hemoglobin
Description
Patients will be subjected to blood samplings
Time Frame
at 3, 6, 9 and 12 months
Title
Adverse effects
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwan KASSIR, MD
Organizational Affiliation
CHU de St Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
St Etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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