NCT07630597Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight/obese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 19 May 2026
- Start date
- 8 May 2026
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Obesity
- NCT number
- NCT07630597
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 8 May 2026 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use within the past 3 months of medications that may significantly affect body weight, including glucocorticoids and antipsychotic agents;
Other illness
- 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;
- Skin infection or damage involving the auricular area;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.