Diabetes depressive state
Conditions
Interventions
taVNS (transcutaneous auricular vagus nerve stimulation) group:Transcutaneous auricular vagus nerve stimulation, select the liver and spleen acupoints on the auricular concha.
sham-taVNS group:The stimulation site was identical to that of the taVNS group, with the minimal stimulation intensity (0.1 mA) serving as a control. All other stimulation parameters and methods were
Sponsors
Beijing First Integrated Traditional Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet diagnostic criteria; patients with first-onset or recurrent depression who have not previously used antidepressant medications or have not received antidepressant treatment for at least 3 months prior to enrollment; aged between 18 and 65 years, gender, right-handed; with a clear history of type 2 diabetes mellitus and meeting the diagnostic criteria for type 2 diabetes as outlined in the "Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)"; with a 17-HAMD score of 7-24 points (patients with depressive symptoms or mild to moderate depression) and not using antidepressant medications during the treatment period; voluntarily adhere to the procedures, requirements, and relevant regulations of this study, and agree to and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: Other diagnosable psychiatric disorders, such as schizophrenia, bipolar affective disorder, anxiety disorders, obsessive-compulsive disorders, mental disorders caused by brain organic diseases, mental disorders caused by psychoactive substances, or comorbid conditions, or those with a family history of mental disorders; individuals with severe suicidal ideation, tendencies, or behaviors; those who have taken glucocorticoids, beta-blockers, diuretics, immunosuppressants, contraceptives, antituberculosis drugs, or other medications that may cause elevated blood glucose levels within the past 4 weeks; those with secondary hyperglycemia caused by other physical illnesses; individuals with heart failure, or abnormal liver or kidney function; female patients who are in the periconceptional period, pregnant, or breastfeeding; those with a history of withdrawal reactions to excessive use of stimulants, hypnotic/sedative drugs, or anti-anxiety medications; those with a history of substance dependence or long-term use of hypnotic drugs; individuals with claustrophobia, metallic implants in the body, or other contraindications for MRI scans; those with severe underlying diseases; or those who have participated in other clinical trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17-item Hamilton Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Fasting Hemoglobin;Homeostatic Model Assessment of Insulin Resistance (HOMA-IR);Resting-state functional magnetic resonance imaging;Metabolomics;Proteomics; | — |
Countries
China
Contacts
Public ContactLi Shao Yuan
Acupuncture Research Institute of the China Academy of Traditional Chinese Medicine
Outcome results
None listed