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Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists

28 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

24

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Yan Bi, MD, PhD
  • Numer telefonu: 6-25-83-105302
  • E-mail: biyan@nju.edu.cn

Kopia zapasowa kontaktu do badania

  • Nazwa: Tian Wei Gu, MD, PhD
  • Numer telefonu: (86) 25-831066 (86) 25-83106666
  • E-mail: gtw0235@163.com

Lokalizacje studiów

  • Chiny
    • Jiangsu
      • Nanjing, Jiangsu, Chiny, 210008
        • Rekrutacyjny
        • Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
        • Kontakt:
          • Tian Wei Gu, MD, PhD
          • Numer telefonu: (86) 25-831066 (86) 25-83106666
          • E-mail: gtw0235@163.com
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. 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;
  2. Willingness to provide written informed consent.

Exclusion Criteria:

  1. 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;
  2. Use within the past 3 months of medications, other than incretin receptor agonists, that may significantly affect body weight, including glucocorticoids and antipsychotic agents;
  3. Skin infection or damage involving the auricular area;
  4. Women planning pregnancy in the near future;
  5. Contraindications to MRI, such as metallic prostheses or claustrophobia;
  6. Diagnosis of diabetes mellitus; Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: transcutaneous auricular vagus nerve stimulation
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.
Inne nazwy:
  • tirzepatide 5 mg
Pozorny komparator: 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.
Urządzenie: Sham
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.
Inne nazwy:
  • tirzepatide 5 mg

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percent Change in Body Weight From Baseline
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Waist Circumference
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in Brain Biotype
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Śledczy

  • Dyrektor Studium: Yan Bi, MD, PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 kwietnia 2026

Zakończenie podstawowe (Szacowany)

14 lipca 2026

Ukończenie studiów (Szacowany)

21 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

18 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 maja 2026

Pierwszy wysłany (Rzeczywisty)

2 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026-0518-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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