Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40
- •Consent Form signed
排除标准
- •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
研究组 & 干预措施
Active stimulation
干预措施: NeuroCoach II Stim (Device)
Inactive stimulation
干预措施: NeuroCoach II Stim (Device)
结局指标
主要结局
Weight
时间窗: at 6 months
the weight (kg) is measured after 6 months of noninvasive stimulation.
次要结局
- Apnea-hypopnea index (AHI)(at 3, 6, 9 and 12 months)
- Systemic inflammation(at 3, 6, 9 and 12 months)
- Patient Health Questionnaire-9 (PHQ-9)(at 3, 6, 9 and 12 months)
- Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)(at 3, 6, 9 and 12 months)
- Blood pressure(at 1, 3, 6, 9 and 12 months)
- Glucagon-like peptide-1 hormone (GLP1)(at 3, 6, 9 and 12 months)
- Glycated hemoglobin(at 3, 6, 9 and 12 months)
- Adverse effects(at 12 months)
- Heart rate variability (HRV)(at 3, 6, 9 and 12 months)
- Octanoylated ghrelin hormone(at 3, 6, 9 and 12 months)
- Peptide tyrosine tyrosine hormone (PYY)(at 3, 6, 9 and 12 months)
- Serum insulin level(at 3, 6, 9 and 12 months)
- Glycemia(at 3, 6, 9 and 12 months)