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NCT07907536Recruiting

Acupuncture Plus Mecobalamin for Diabetic Cardiac Autonomic Neuropathy

Efficacy and Safety of Acupuncture at Xinshu (BL15), Jueyinshu (BL14) and Yishu (EX-B3) for Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn whether acupuncture can improve damage to the nerves that control the heart (cardiac autonomic neuropathy) in adults with type 2 diabetes. It will also learn about the safety of this acupuncture treatment. The main questions it aims to answer are: Does acupuncture at three points on the back (Xinshu, Jueyinshu and Yishu), added to standard treatment, improve symptoms such as palpitations, chest tightness, fatigue and numbness? Does it improve test results that measure how well the heart's nerves work? Researchers will compare acupuncture plus mecobalamin (a form of vitamin B12) with mecobalamin alone to see whether adding acupuncture works better. Participants will: Continue their usual diabetes treatment and take mecobalamin tablets by mouth three times a day If assigned to the acupuncture group, receive acupuncture 3 times a week for 6 weeks, about 15 minutes each session Have blood tests, heart nerve function tests and symptom questionnaires at the start of the study and again at week 6

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
25 Oct 2026
Start date
1 May 2025
Primary completion date
30 Dec 2027
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT number
NCT07907536

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 May 2025 to the primary completion date, 30 Dec 2027
  • 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.

Other illness

  • Acute complications or severe chronic complications of diabetes
  • Acute cardiovascular disease, such as acute coronary syndrome, pulmonary embolism or ruptured aortic dissection
  • Acute infection, recent surgery, trauma or other stress states
  • Use of drugs that affect the heart, such as beta-blockers, atropine or digitalis, within the past 2 weeks
  • Severe heart, liver, lung or kidney insufficiency, or a history of malignancy
  • Diseases other than type 2 diabetes that may cause neuropathy, including: metabolic diseases (thyroid dysfunction, hypertriglyceridemia, amyloidosis); connective tissue diseases; inflammatory neurovascular diseases (Guillain-Barre syndrome, polyradiculopathy, cerebral infarction); psychiatric disorders (anxiety, depression, schizophrenia); nutritional deficiencies (vitamin B6, B12, E, etc.); alcohol dependence; exposure to neurotoxic agents (chemotherapy drugs, heavy metals, chemical products); and chronic infectious diseases (hepatitis B, syphilis, HIV infection)
  • Unable to cooperate with testing because of cognitive impairment or intellectual factors

Other

  • Primary cardiomyopathy, such as dilated, hypertrophic, restrictive, arrhythmogenic right ventricular or unclassified cardiomyopathy
  • Use of alcohol, caffeine or sedatives within the past 24 hours

Who the study is looking for

  • Aged 18 to 70 years
  • Diagnosed with type 2 diabetes according to the 1999 WHO diagnostic criteria
  • Cardiovascular autonomic neuropathy confirmed by cardiovascular autonomic reflex tests (CARTs)

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.