Acupuncture plus vitamin B12 for diabetic heart nerve damage

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 interventional study investigates whether acupuncture at three back points (Xinshu, Jueyinshu, Yishu) in addition to mecobalamin (vitamin B12) and usual diabetes care can improve symptoms related to cardiac autonomic neuropathy and improve heart nerve function in adults with type 2 diabetes. Participants are randomized to receive acupuncture three times weekly for six weeks alongside mecobalamin, or mecobalamin alone, with ongoing diabetes management. Outcomes include symptom changes and tests of cardiovascular autonomic reflexes, as well as safety measures. Eligible adults are 18 to 70 with type 2 diabetes and confirmed cardiovascular autonomic neuropathy; several medical exclusions apply. The lead sponsor is The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, with sites in Nanjing, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Acute complications or severe chronic complications of diabetes
* Primary cardiomyopathy, such as dilated, hypertrophic, restrictive, arrhythmogenic right ventricular or unclassified cardiomyopathy
* 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
* Use of alcohol, caffeine or sedatives within the past 24 hours
* 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

Where it's running

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

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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.