Transcutaneous auricular vagus nerve stimulation plus lifestyle for poor weight-loss responders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, single-blind, sham-controlled pilot trial will compare taVNS plus lifestyle intervention versus sham plus lifestyle intervention in adults with overweight or obesity who showed poor weight loss after 12 weeks of structured lifestyle programs. Participants will be randomized 1:1 to receive 12 weeks of taVNS or sham stimulation in addition to standardized diet and exercise guidance. Primary outcome is the percent change in body weight from baseline after 12 weeks of intervention; secondary outcomes include body composition, fat distribution, autonomic function, liver parameters, and metabolic markers. The study will enroll 24 participants and is conducted at the Affiliated Drum Tower Hospital in Nanjing, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;
2. Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;
3. 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);
4. 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 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. Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.

Where it's running

• Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yan Bi, MD, PhD
• Email: biyan@nju.edu.cn
• Phone: 6-25-83-105302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.