Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
2026年7月30日 更新者：Yan Bi、The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Adjunctive Transcutaneous Auricular Vagus Nerve Stimulation in Overweight or Obese Patients With a Suboptimal Weight-Loss Response to Incretin Receptor Agonists: A Single-Center, Randomized, Sham-Controlled Study
This is a single-center, randomized, participant-blinded, sham-controlled trial designed to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight or obese patients who show a suboptimal weight-loss response to incretin receptor agonist therapy.
A total of 24 participants will be randomly assigned to receive either taVNS plus tirzepatide 5 mg or sham stimulation plus tirzepatide 5 mg for 12 weeks.
The primary objective is to compare the percent change in body weight from baseline to week 12 between the two groups.
研究概览
详细说明
This is a prospective, single-center, randomized, participant-blinded, sham-controlled, parallel-group study conducted at the Department of Endocrinology, Nanjing Drum Tower Hospital. The study will enroll 24 overweight or obese participants with a suboptimal weight-loss response, defined as a body weight reduction of no more than 10% after at least 12 weeks of tirzepatide treatment. Eligible participants will be randomized in a 1:1 ratio to the taVNS plus tirzepatide 5 mg group or the sham stimulation plus tirzepatide 5 mg group for 12 weeks.
Before and after intervention, all participants will undergo standardized assessments, including lifestyle questionnaires, anthropometric measurements, body composition analysis, autonomic function evaluation, laboratory testing, and assessment of hepatic steatosis and fibrosis. Autonomic function assessment will include heart rate variability, cardiovascular autonomic reflex tests, sudomotor function, and brain MRI. Liver-related assessments will include FibroTouch and liver MRI. During follow-up, body weight will be monitored weekly by telephone or WeChat, waist circumference, hip circumference, and body composition will be reassessed every 4 weeks, and device use will be monitored through an app to ensure adherence and protocol consistency.
The primary endpoint is the between-group difference in percent change in body weight from baseline to week 12. Secondary endpoints include changes in body composition and fat distribution, glucose- and lipid-related metabolic parameters, liver function and hepatic steatosis/fibrosis-related parameters, and autonomic function measures. Exploratory analyses will evaluate changes in brain imaging phenotypes after 12 weeks of intervention.
研究类型
介入性
注册 (估计的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yan Bi, MD, PhD
- 电话号码：6-25-83-105302
- 邮箱：biyan@nju.edu.cn
研究联系人备份
- 姓名：Tian Wei Gu, MD, PhD
- 电话号码：(86) 25-831066 (86) 25-83106666
- 邮箱：gtw0235@163.com
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210008
- 招聘中
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
-
接触：
- Tian Wei Gu, MD, PhD
- 电话号码：(86) 25-831066 (86) 25-83106666
- 邮箱：gtw0235@163.com
-
接触：
- Yan Bi, MD,PhD
- 电话号码：6-25-83-105302
- 邮箱：biyan@nju.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Individuals with obesity, or overweight accompanied by at least one weight-related comorbidity (e.g., hypertension or fatty liver disease), who have been receiving tirzepatide therapy for at least 12 weeks and have achieved ≤10% weight loss during treatment;
- Willingness to provide written informed consent.
Exclusion Criteria:
- Presence of diseases that may substantially affect body weight homeostasis, including Cushing's syndrome, uncontrolled thyroid disease (thyroid-stimulating hormone >6.0 mIU/L or <0.4 mIU/L), malignancy, or similar conditions;
- Use within the past 3 months of medications, other than incretin receptor agonists, that may significantly affect body weight, including glucocorticoids and antipsychotic agents;
- Skin infection or damage involving the auricular area;
- Women planning pregnancy in the near future;
- Contraindications to MRI, such as metallic prostheses or claustrophobia;
- Diagnosis of diabetes mellitus; Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：taVNS Plus Tirzepatide 5 mg
Participants will receive active transcutaneous auricular vagus nerve stimulation plus tirzepatide 5 mg for 12 weeks.
Active stimulation will be delivered to the bilateral cymba conchae, an auricular region innervated by the auricular branch of the vagus nerve.
Stimulation will use an intermittent waveform of 15 seconds on and 5 seconds off at 20 Hz, with a pulse width of 0.2 ms.
Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA.
Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks.
Tirzepatide will be administered as a subcutaneous injection once weekly.
|
Participants will receive active transcutaneous auricular vagus nerve stimulation plus tirzepatide 5 mg for 12 weeks.
Active stimulation will be delivered to the bilateral cymba conchae, an auricular region innervated by the auricular branch of the vagus nerve.
Stimulation will use an intermittent waveform of 15 seconds on and 5 seconds off at 20 Hz, with a pulse width of 0.2 ms.
Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA.
Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks.
Tirzepatide will be administered as a subcutaneous injection once weekly.
其他名称：
|
|
假比较器：Sham Stimulation Plus Tirzepatide 5 mg
Participants will receive sham stimulation in addition to tirzepatide 5 mg for 12 weeks.
Sham stimulation will be applied to the bilateral tail of the helix, an auricular site without vagus nerve distribution, whereas active taVNS targets the cymba conchae, which is innervated by the auricular branch of the vagus nerve.
The sham group will use the same waveform parameters, stimulation intensity titration, and treatment schedule as the active group, namely twice daily for 30 minutes per session, 5 days per week, for 12 weeks.
Tirzepatide will be administered as a subcutaneous injection once weekly.
|
Participants will receive sham stimulation in addition to tirzepatide 5 mg for 12 weeks.
Sham stimulation will be applied to the bilateral tail of the helix, an auricular site without vagus nerve distribution, whereas active taVNS targets the cymba conchae, which is innervated by the auricular branch of the vagus nerve.
The sham group will use the same waveform parameters, stimulation intensity titration, and treatment schedule as the active group, namely twice daily for 30 minutes per session, 5 days per week, for 12 weeks.
Tirzepatide will be administered as a subcutaneous injection once weekly.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Change in Body Weight From Baseline
大体时间：Baseline, 4 weeks, 8 weeks, 12 weeks
|
Percent change in body weight from baseline to week 12 will be compared between the taVNS plus tirzepatide group and the sham stimulation plus tirzepatide group to evaluate the adjunctive effect of taVNS on weight reduction.
|
Baseline, 4 weeks, 8 weeks, 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Waist Circumference
大体时间：Baseline, Week 4, Week 8, Week 12
|
Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement.
|
Baseline, Week 4, Week 8, Week 12
|
|
Change in Body Composition and Fat Distribution
大体时间：Baseline, ,Week 4, Week 8, Week 12
|
Changes in body composition and fat distribution will be assessed by body fat percentage using anthropometric measurements and body composition analysis.
|
Baseline, ,Week 4, Week 8, Week 12
|
|
Change in blood glucose
大体时间：Baseline, Week 12
|
Change in fasting blood glucose from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
|
Change in Hip Circumference
大体时间：Baseline, Week 4, Week 8, Week 12
|
Change in hip circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement.
|
Baseline, Week 4, Week 8, Week 12
|
|
Change in Visceral Fat Area
大体时间：Baseline, Week 4, Week 8, Week 12
|
Change in visceral fat area from baseline to Week 4, Week 8, and Week 12 will be assessed using body composition analysis.
|
Baseline, Week 4, Week 8, Week 12
|
|
Change in Glycated Hemoglobin
大体时间：Baseline, Week 12
|
Change in glycated hemoglobin (HbA1c) from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
|
Change in High-Density Lipoprotein Cholesterol
大体时间：Baseline, Week 12
|
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
|
Change in Low-Density Lipoprotein Cholesterol
大体时间：Baseline, Week 12
|
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
|
Change in Triglycerides
大体时间：Baseline, Week 12
|
Change in triglycerides from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
|
Change in Controlled Attenuation Parameter
大体时间：Baseline, Week 12
|
Change in controlled attenuation parameter (CAP) from baseline to Week 12 will be assessed using transient elastography.
|
Baseline, Week 12
|
|
Change in Liver Stiffness Measurement
大体时间：Baseline, Week 12
|
Change in liver stiffness measurement (LSM) from baseline to Week 12 will be assessed using transient elastography.
|
Baseline, Week 12
|
|
Change in Liver Function
大体时间：Baseline, Week 12
|
Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
|
Change in Heart Rate Variability
大体时间：Baseline, Week 12
|
Change in heart rate variability from baseline to Week 12 will be assessed using time-domain and/or frequency-domain heart rate variability analysis.
|
Baseline, Week 12
|
|
Change in Cardiovascular Autonomic Reflex Test Result
大体时间：Baseline, Week 12
|
Change in cardiovascular autonomic reflex function from baseline to Week 12 will be assessed using standardized cardiovascular autonomic reflex testing.
|
Baseline, Week 12
|
|
Change in Central Autonomic Network Functional Connectivity
大体时间：Baseline, Week 12
|
Change in central autonomic network features from baseline to Week 12 will be assessed using brain MRI-based functional connectivity analysis.
|
Baseline, Week 12
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Brain Biotype
大体时间：Baseline, Week 12
|
Changes in brain biotype after 12 weeks of intervention will be explored using brain MRI-based analyses.
Brain biotype will be assessed at baseline and Week 12 using brain MRI-based analyses.
Brain biotype will be defined as an MRI-derived classification based on pre-specified brain imaging features, such as resting-state functional connectivity patterns.
Participants will be assigned to a brain biotype category according to the pre-specified MRI analysis algorithm.
|
Baseline, Week 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Yan Bi, MD, PhD、Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.