Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention
Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight/Obese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Obesity is a chronic metabolic disease with substantial health consequences, and lifestyle intervention remains the foundation of weight management. However, a considerable proportion of overweight or obese individuals fail to achieve clinically meaningful weight loss after structured lifestyle intervention. In this study, patients with poor response to lifestyle intervention are defined as those who have completed 12 weeks of lifestyle intervention with weight loss of 5% or less.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that stimulates the auricular branch of the vagus nerve and may improve autonomic balance, appetite regulation, and energy metabolism. This study is designed to investigate whether taVNS can enhance weight loss and improve metabolic outcomes when used as an adjunct to lifestyle intervention in overweight/obese patients with poor early response.
A total of 24 participants will be enrolled at a single center and randomized in a 1:1 ratio to either the taVNS plus lifestyle intervention group or the sham stimulation plus lifestyle intervention group. The intervention period will last 12 weeks. All participants will receive standardized lifestyle guidance including dietary management and exercise management. Dietary intervention will be individualized based on basal metabolic rate measured by InBody and guided by the Dietary Guidelines for Chinese Residents, with an intended daily energy deficit of approximately 500 kcal. Exercise management will require at least 3 days of moderate-to-high intensity physical activity per week, with a total duration of at least 150 minutes, monitored by a wearable device.
Participants in the active treatment group will receive taVNS applied to the left cymba conchae using an intermittent electrical stimulation pattern (15 seconds on, 5 seconds off), frequency of 20 Hz, pulse width of 0.2 ms, and intensity gradually increased to a tolerable mild tingling sensation, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes each time, 5 times per week, for 12 weeks. Participants in the control group will receive sham stimulation at the left tail of the helix, with the same stimulation schedule and device settings.
Assessments will be performed at baseline and after 12 weeks of intervention, including anthropometric measurements, body composition analysis, autonomic function testing, laboratory testing, and evaluation of hepatic steatosis and fibrosis using FibroTouch and liver MRI. The primary endpoint is percent change in body weight from baseline at week 12. Secondary endpoints include changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yan Bi, MD, PhD
- Número de teléfono: 6-25-83-105302
- Correo electrónico: biyan@nju.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Tian Wei Gu, MD, PhD
- Correo electrónico: gtw0235@163.com
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210008
- Reclutamiento
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
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Contacto:
- Tian Wei Gu, MD, PhD
- Número de teléfono: (86) 25-831066 (86) 25-83106666
- Correo electrónico: gtw0235@163.com
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Contacto:
- Yan Bi, MD,PhD
- Número de teléfono: 6-25-83-105302
- Correo electrónico: biyan@nju.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;
- Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;
- Current body mass index (BMI) ≥28 kg/m², or BMI ≥24 kg/m² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease);
- 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 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;
- Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: taVNS Plus Lifestyle Intervention
Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle intervention for 12 weeks.
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Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle Intervention for 12 weeks.
Active stimulation will be delivered to the left cymba conchae using an intermittent waveform (15 seconds on, 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.
Otros nombres:
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Comparador falso: Sham Stimulation plus Lifestyle Intervention
Participants will receive sham stimulation in addition to standardized lifestyle intervention for 12 weeks
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Participants will receive sham stimulation in addition to lifestyle Intervention for 12 weeks.
Sham stimulation will be applied to the left tail of the helix using 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change in Body Weight From Baseline
Periodo de tiempo: Baseline, 4 weeks, 8 weeks, 12 weeks
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Percent change in body weight from baseline to week 12 will be compared between the taVNS plus lifestyle intervention group and the sham stimulation plus lifestyle intervention group to evaluate the adjunctive effect of taVNS on weight reduction.
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Baseline, 4 weeks, 8 weeks, 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in blood glucose
Periodo de tiempo: Baseline, Week 12
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Change in fasting blood glucose from baseline to Week 12 will be assessed using laboratory testing.
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Baseline, Week 12
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Change in Glycated Hemoglobin
Periodo de tiempo: Baseline, Week 12
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Change in glycated hemoglobin (HbA1c) from baseline to Week 12 will be assessed using laboratory testing.
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Baseline, Week 12
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Change in High-Density Lipoprotein Cholesterol
Periodo de tiempo: Baseline, Week 12
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Change in high-density lipoprotein cholesterol (HDL-C) from baseline to Week 12 will be assessed using laboratory testing.
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Baseline, Week 12
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Change in Low-Density Lipoprotein Cholesterol
Periodo de tiempo: Baseline, Week 12
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Change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 12 will be assessed using laboratory testing.
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Baseline, Week 12
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Change in Triglycerides
Periodo de tiempo: Baseline, Week 12
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Change in triglycerides from baseline to Week 12 will be assessed using laboratory testing.
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Baseline, Week 12
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Change in Controlled Attenuation Parameter
Periodo de tiempo: Baseline, Week 12
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Change in controlled attenuation parameter (CAP) from baseline to Week 12 will be assessed using transient elastography.
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Baseline, Week 12
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Change in Liver Stiffness Measurement
Periodo de tiempo: Baseline, Week 12
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Change in liver stiffness measurement (LSM) from baseline to Week 12 will be assessed using transient elastography.
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Baseline, Week 12
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Change in Liver Function
Periodo de tiempo: Baseline, Week 12
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Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline to Week 12 will be assessed using laboratory testing.
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Baseline, Week 12
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Change in Heart Rate Variability
Periodo de tiempo: Baseline, Week 12
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Change in heart rate variability from baseline to Week 12 will be assessed using time-domain and/or frequency-domain heart rate variability analysis.
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Baseline, Week 12
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Change in Cardiovascular Autonomic Reflex Test Result
Periodo de tiempo: Baseline, Week 12
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Change in cardiovascular autonomic reflex function from baseline to Week 12 will be assessed using standardized cardiovascular autonomic reflex testing.
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Baseline, Week 12
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Change in Waist Circumference
Periodo de tiempo: Baseline, ,Week 4, Week 8, Week 12
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Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement. 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
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Change in Body Composition and Fat Distribution
Periodo de tiempo: Baseline, ,Week 4, Week 8, Week 12
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Changes in body composition and fat distribution will be assessed by body fat percentage using anthropometric measurements and body composition analysis
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Baseline, ,Week 4, Week 8, Week 12
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Change in Visceral Fat Area
Periodo de tiempo: Baseline, ,Week 4, Week 8, Week 12
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Change in visceral fat area from baseline to Week 4, Week 8, and Week 12 will be assessed using body composition analysis.
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Baseline, ,Week 4, Week 8, Week 12
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Change in Hip Circumference
Periodo de tiempo: Baseline, ,Week 4, Week 8, Week 12
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Change in hip circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement.
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Baseline, ,Week 4, Week 8, Week 12
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Change in Insulin Resistance
Periodo de tiempo: Baseline, Week 12
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Change in insulin resistance from baseline to Week 12 will be assessed using the homeostatic model assessment of insulin resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels.
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Baseline, Week 12
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Brain Biotype
Periodo de tiempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0518-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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