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Efficacy Evaluation and Mechanism Exploration of Transcutaneous Auricular Electrical Stimulation in Enhancing Semaglutide Effectiveness and Reducing Gastrointestinal Side Effects

Efficacy Evaluation and Mechanism Exploration of taVNS in Enhancing Semaglutide Efficacy and Reducing Gastrointestinal Side Effects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000220
Enrollment
Unknown
Registered
2026-01-30
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes or Obesity/Overweight Comorbidities

Interventions

Experimental Group:Basic treatment+Transcutaneous Auricular Electrical Stimulation
Control Group:Basic treatment+Non-Auricular Electrical Stimulation on External Ear

Sponsors

Guang'anmen Hospital of the Chinese Academy of Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet diagnostic criteria for type 2 diabetes, obesity, or overweight comorbidities: Type 2 diabetes patients must have fasting blood glucose =126 mg/dL (7.0 mmol/L), HbA1c =6.5%, or 2-hour postprandial blood glucose =200 mg/dL (11.1 mmol/L); obesity patients must have BMI =30 kg/m²; overweight patients with comorbidities must have BMI =27 kg/m² and at least one complication such as hypertension or dyslipidemia. 2. Age 18-70 years. 3. Experience gastrointestinal symptoms (e.g., nausea, vomiting) after semaglutide injection with RINVR score =20 and =32. 4. Voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants with severe cardiovascular, cerebrovascular, hepatic, hematopoietic system diseases, or other life-threatening conditions. 2. Participants with hepatic/renal insufficiency or cirrhosis. 3. Participants with fever or infectious diseases. 4. Pregnant or lactating women. 5. Participants with psychiatric disorders or inability to cooperate with treatment. 6. Participants with cardiac pacemakers or allergies to trial interventions. 7. Participants using prokinetic drugs or medications alleviating gastrointestinal side effects (e.g., ondansetron, metoclopramide, dexamethasone). 8. Participants with gastrointestinal disorders causing nausea/vomiting (e.g., diabetic gastroparesis). 9. Participants with acute pancreatitis, diabetic retinopathy, or thyroid diseases. 10. Participants with diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within 6 months, or fasting blood glucose =13.9 mmol/L (250 mg/dL), HbA1c =10%, or random blood glucose =16.7 mmol/L (300 mg/dL). 11. Participation in other clinical trials within 3 months with potential interference.

Design outcomes

Primary

MeasureTime frame
Rhodes Index of Nausea, Vomiting, and Retching(RINVR);

Secondary

MeasureTime frame
Simplified Nutritional Appetite Questionnaire (SNAQ);Visual Analog Scale(VAS);Serological Indicators;Anthropometric Indicators;Gastrointestinal Symptom Rating Scale;

Countries

China

Contacts

Public ContactWenke Liu

Guang'anmen Hospital of the Chinese Academy of Traditional Medicine

liuwenke1209@sina.com+86 15801247725

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026