Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
30 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
24
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Yan Bi, MD, PhD
- Telefoonnummer: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
Studie Contact Back-up
- Naam: Tian Wei Gu, MD, PhD
- Telefoonnummer: (86) 25-831066 (86) 25-83106666
- E-mail: gtw0235@163.com
Studie Locaties
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Werving
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
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Contact:
- Tian Wei Gu, MD, PhD
- Telefoonnummer: (86) 25-831066 (86) 25-83106666
- E-mail: gtw0235@163.com
-
Contact:
- Yan Bi, MD,PhD
- Telefoonnummer: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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Sham-vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percent Change in Body Weight From Baseline
Tijdsspanne: 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 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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Waist Circumference
Tijdsspanne: 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 anthropometric measurement.
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Baseline, Week 4, Week 8, Week 12
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Change in Body Composition and Fat Distribution
Tijdsspanne: 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 blood glucose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Week 12
|
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
Tijdsspanne: 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
Tijdsspanne: 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.
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Baseline, Week 12
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Change in Cardiovascular Autonomic Reflex Test Result
Tijdsspanne: 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 Central Autonomic Network Functional Connectivity
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Brain Biotype
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Yan Bi, MD, PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
1 juni 2027
Studie voltooiing (Geschat)
1 september 2027
Studieregistratiedata
Eerst ingediend
18 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 mei 2026
Eerst geplaatst (Werkelijk)
2 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
30 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-0518-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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