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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00253-46 | Other Identifier | ANSM |
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Lack of inclusion and departure of the investigator
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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental |
| |
| Inactive stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroCoach II Stim | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | the weight (kg) is measured after 6 months of noninvasive stimulation. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability (HRV) | HRV is measured by a 24H-Holter Electrocardiography (ECG). It is a composite outcome :
| at 3, 6, 9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radwan KASSIR, MD | CHU de St Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42000 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| NeuroCoach II Stim | Device | 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. |
|
|
| 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 |
| Apnea-hypopnea index (AHI) | AHI is analyzed by a polysomnography in an outpatient setting. | at 3, 6, 9 and 12 months |
| Patient Health Questionnaire-9 (PHQ-9) | It is a anxiety scale | at 3, 6, 9 and 12 months |
| Blood pressure | at 1, 3, 6, 9 and 12 months |
| Octanoylated ghrelin hormone | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months |
| Glucagon-like peptide-1 hormone (GLP1) | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months |
| Peptide tyrosine tyrosine hormone (PYY) | Patients will be subjected to blood samplings | 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 | at 3, 6, 9 and 12 months |
| Serum insulin level | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months |
| Glycemia | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months |
| Glycated hemoglobin | Patients will be subjected to blood samplings | 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. | at 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |