Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
30 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
24
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yan Bi, MD, PhD
- Número de telefone: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
Estude backup de contato
- Nome: Tian Wei Gu, MD, PhD
- Número de telefone: (86) 25-831066 (86) 25-83106666
- E-mail: gtw0235@163.com
Locais de estudo
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210008
- Recrutamento
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
-
Contato:
- Tian Wei Gu, MD, PhD
- Número de telefone: (86) 25-831066 (86) 25-83106666
- E-mail: gtw0235@163.com
-
Contato:
- Yan Bi, MD,PhD
- Número de telefone: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
|
|
Comparador Falso: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percent Change in Body Weight From Baseline
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Waist Circumference
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Brain Biotype
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Diretor de estudo: Yan Bi, MD, PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de junho de 2027
Conclusão do estudo (Estimado)
1 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
18 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
2 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-0518-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .