Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
30 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
24
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yan Bi, MD, PhD
- Numéro de téléphone: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
Sauvegarde des contacts de l'étude
- Nom: Tian Wei Gu, MD, PhD
- Numéro de téléphone: (86) 25-831066 (86) 25-83106666
- E-mail: gtw0235@163.com
Lieux d'étude
-
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Jiangsu
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Nanjing, Jiangsu, Chine, 210008
- Recrutement
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
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Contact:
- Tian Wei Gu, MD, PhD
- Numéro de téléphone: (86) 25-831066 (86) 25-83106666
- E-mail: gtw0235@163.com
-
Contact:
- Yan Bi, MD,PhD
- Numéro de téléphone: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur factice: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percent Change in Body Weight From Baseline
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Waist Circumference
Délai: 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
Délai: 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
Délai: Baseline, Week 12
|
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
Délai: 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
Délai: 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
|
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Change in Glycated Hemoglobin
Délai: Baseline, Week 12
|
Change in glycated hemoglobin (HbA1c) from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
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Change in High-Density Lipoprotein Cholesterol
Délai: 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
|
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Change in Low-Density Lipoprotein Cholesterol
Délai: 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
|
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Change in Triglycerides
Délai: Baseline, Week 12
|
Change in triglycerides from baseline to Week 12 will be assessed using laboratory testing.
|
Baseline, Week 12
|
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Change in Controlled Attenuation Parameter
Délai: Baseline, Week 12
|
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
Délai: Baseline, Week 12
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Change in liver stiffness measurement (LSM) from baseline to Week 12 will be assessed using transient elastography.
|
Baseline, Week 12
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Change in Liver Function
Délai: 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
Délai: 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
Délai: 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
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Change in Central Autonomic Network Functional Connectivity
Délai: 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
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Brain Biotype
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Yan Bi, MD, PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 juin 2027
Achèvement de l'étude (Estimé)
1 septembre 2027
Dates d'inscription aux études
Première soumission
18 mai 2026
Première soumission répondant aux critères de contrôle qualité
28 mai 2026
Première publication (Réel)
2 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0518-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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