Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Electroacupuncture: The electroacupuncture protocol each session will involve a needle
retention time of 30 minutes (totally 20-24 session). Acupuncture points selected for intervention
Sponsors
Dr Kalaiselvan G
Eligibility
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion are adults diagnosed with Diabetes Mellitus according to American Diabetes Association (ADA) criteria for a duration of five years or more, with glycemic control indicating an HbA1c level greater than 6.5%. Additionally, participants must have a confirmed diagnosis of cardiac autonomic neuropathy, established by the presence of at least two abnormal findings in Ewing s battery of autonomic function tests. All participants must be willing and able to provide written informed consent prior to enrollment in the study.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they have medical conditions other than diabetes that could independently affect autonomic function, including chronic alcoholism, history of chemotherapy, or vitamin B12 deficiency. Individuals with established cardiovascular disease or those using a pacemaker will also be excluded. Additionally, participants with neurological or psychiatric conditions such as epilepsy, depression, or panic disorder will not be eligible. Subjects presenting with open wounds, scalds, or burns at the intended site of intervention will be excluded to avoid procedural complications. Finally, individuals who have a known phobia of acupuncture or are unwilling to undergo the procedure will not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the assessment of cardiac autonomic function using Ewing s battery of autonomic function tests. This includes evaluation through the deep breathing test, Valsalva manoeuvre, and the lying-to-standing test (30:15 ratio) to assess parasympathetic function, along with measurement of blood pressure response to standing and blood pressure response to sustained handgrip to assess sympathetic function. Abnormalities identified across these tests will be used to determine changes in autonomic function following the intervention.Timepoint: 8-10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom severity - The Composite Autonomic Symptom Score (COMPASS-31)Timepoint: 8-10 weeks | — |
Countries
India
Contacts
Public ContactDr Geethanjali S
International Institute of Yoga and Naturopathy Medical Sciences
Outcome results
None listed