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

2026年7月30日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

24

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Yan Bi, MD, PhD
  • 電話番号：6-25-83-105302
  • メール：biyan@nju.edu.cn

研究連絡先のバックアップ

  • 名前：Tian Wei Gu, MD, PhD
  • 電話番号：(86) 25-831066 (86) 25-83106666
  • メール：gtw0235@163.com

研究場所

  • 中国
    • Jiangsu
      • Nanjing、Jiangsu、中国、210008
        • 募集
        • Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
        • コンタクト：
          • Tian Wei Gu, MD, PhD
          • 電話番号：(86) 25-831066 (86) 25-83106666
          • メール：gtw0235@163.com
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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 tirzepatide therapy for at least 12 weeks 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
他の名前：
  • tirzepatide 5 mg
偽コンパレータ：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.
デバイス：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.
他の名前：
  • tirzepatide 5 mg

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percent Change in Body Weight From Baseline
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Waist Circumference
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Brain Biotype
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

捜査官

  • スタディディレクター：Yan Bi, MD, PhD、Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2026年5月18日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月31日

QC基準を満たした最後の更新が送信されました

2026年7月30日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-0518-01

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