Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention
Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight/Obese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Obesity is a chronic metabolic disease with substantial health consequences, and lifestyle intervention remains the foundation of weight management. However, a considerable proportion of overweight or obese individuals fail to achieve clinically meaningful weight loss after structured lifestyle intervention. In this study, patients with poor response to lifestyle intervention are defined as those who have completed 12 weeks of lifestyle intervention with weight loss of 5% or less.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that stimulates the auricular branch of the vagus nerve and may improve autonomic balance, appetite regulation, and energy metabolism. This study is designed to investigate whether taVNS can enhance weight loss and improve metabolic outcomes when used as an adjunct to lifestyle intervention in overweight/obese patients with poor early response.
A total of 24 participants will be enrolled at a single center and randomized in a 1:1 ratio to either the taVNS plus lifestyle intervention group or the sham stimulation plus lifestyle intervention group. The intervention period will last 12 weeks. All participants will receive standardized lifestyle guidance including dietary management and exercise management. Dietary intervention will be individualized based on basal metabolic rate measured by InBody and guided by the Dietary Guidelines for Chinese Residents, with an intended daily energy deficit of approximately 500 kcal. Exercise management will require at least 3 days of moderate-to-high intensity physical activity per week, with a total duration of at least 150 minutes, monitored by a wearable device.
Participants in the active treatment group will receive taVNS applied to the left cymba conchae using an intermittent electrical stimulation pattern (15 seconds on, 5 seconds off), frequency of 20 Hz, pulse width of 0.2 ms, and intensity gradually increased to a tolerable mild tingling sensation, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes each time, 5 times per week, for 12 weeks. Participants in the control group will receive sham stimulation at the left tail of the helix, with the same stimulation schedule and device settings.
Assessments will be performed at baseline and after 12 weeks of intervention, including anthropometric measurements, body composition analysis, autonomic function testing, laboratory testing, and evaluation of hepatic steatosis and fibrosis using FibroTouch and liver MRI. The primary endpoint is percent change in body weight from baseline at week 12. Secondary endpoints include changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
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
- E-mail: gtw0235@163.com
Lokalizacje studiów
-
-
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:
- Yan Bi, MD,PhD
- Numer telefonu: 6-25-83-105302
- E-mail: biyan@nju.edu.cn
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;
- Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;
- Current body mass index (BMI) ≥28 kg/m², or BMI ≥24 kg/m² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease);
- 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 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;
- Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.
Plan studiów
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 Lifestyle Intervention
Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle intervention for 12 weeks.
|
Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle Intervention for 12 weeks.
Active stimulation will be delivered to the left cymba conchae using an intermittent waveform (15 seconds on, 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.
Inne nazwy:
|
|
Pozorny komparator: Sham Stimulation plus Lifestyle Intervention
Participants will receive sham stimulation in addition to standardized lifestyle intervention for 12 weeks
|
Participants will receive sham stimulation in addition to lifestyle Intervention for 12 weeks.
Sham stimulation will be applied to the left tail of the helix using 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.
Inne nazwy:
|
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 lifestyle intervention group and the sham stimulation plus lifestyle intervention 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 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 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 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 Change in waist circumference from baseline to Week 4, Week 8, and Week 12 will be assessed using standardized anthropometric measurement. 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 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 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 Insulin Resistance
Ramy czasowe: Baseline, Week 12
|
Change in insulin resistance from baseline to Week 12 will be assessed using the homeostatic model assessment of insulin resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels.
|
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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-0518-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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 .