Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
28 maggio 2026 aggiornato da: 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 Pilot Study
This is a single-center, randomized, participant-blinded, sham-controlled pilot 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a prospective, single-center, randomized, participant-blinded, sham-controlled, parallel-group pilot 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 24 weeks of incretin receptor agonist 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 di studio
Interventistico
Iscrizione (Stimato)
24
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Yan Bi, MD, PhD
- Numero di telefono: 6-25-83-105302
- Email: biyan@nju.edu.cn
Backup dei contatti dello studio
- Nome: Tian Wei Gu, MD, PhD
- Numero di telefono: (86) 25-831066 (86) 25-83106666
- Email: gtw0235@163.com
Luoghi di studio
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Jiangsu
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Nanjing, Jiangsu, Cina, 210008
- Reclutamento
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
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Contatto:
- Tian Wei Gu, MD, PhD
- Numero di telefono: (86) 25-831066 (86) 25-83106666
- Email: gtw0235@163.com
-
Contatto:
- Yan Bi, MD,PhD
- Numero di telefono: 6-25-83-105302
- Email: biyan@nju.edu.cn
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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 incretin receptor agonist therapy for at least 6 months 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Comparatore fittizio: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent Change in Body Weight From Baseline
Lasso di tempo: 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.
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Baseline, 4 weeks, 8 weeks, 12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Waist Circumference
Lasso di tempo: 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.
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Baseline, Week 4, Week 8, Week 12
|
|
Change in Body Composition and Fat Distribution
Lasso di tempo: 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
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Change in blood glucose
Lasso di tempo: 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 Hip Circumference
Lasso di tempo: 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.
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Baseline, Week 4, Week 8, Week 12
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Change in Visceral Fat Area
Lasso di tempo: 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 Glycated Hemoglobin
Lasso di tempo: Baseline, Week 12
|
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
Lasso di tempo: Baseline, Week 12
|
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
Lasso di tempo: Baseline, Week 12
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 12
|
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
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 12
|
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 Central Autonomic Network Functional Connectivity
Lasso di tempo: Baseline, Week 12
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Change in central autonomic network features from baseline to Week 12 will be assessed using brain MRI-based functional connectivity analysis.
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Baseline, Week 12
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Brain Biotype
Lasso di tempo: 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.
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Baseline, Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Yan Bi, MD, PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
21 aprile 2026
Completamento primario (Stimato)
14 luglio 2026
Completamento dello studio (Stimato)
21 luglio 2026
Date di iscrizione allo studio
Primo inviato
18 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 maggio 2026
Primo Inserito (Effettivo)
2 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-0518-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su transcutaneous auricular vagus nerve stimulation
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