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A study to find whether Nerve damage in the hands and feet is related to heart nerve problems in people with Type 2 Diabetes

A Study of the correlation between Diabetic Peripheral Neuropathy and Cardiac Autonomic Neuropathy in patients with Type 2 Diabetes Mellitus - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/105259
Enrollment
100
Registered
2026-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: E084- Diabetes mellitus due to underlying condition with neurological complications

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Dr Kuchkar Snehal Sanjay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged more than 30 years diagnosed with type 2 diabetes mellitus according to ADA criteria Duration of diabetes equal to or more than 5 years Availability of recent baseline labs within 3 months including HbA1c and serum creatinine Patients who provide written informed consent to participate in the study Patients who are able to undergo detailed neurological and cardiac autonomic function assessments

Exclusion criteria

Exclusion criteria: Patients with type 1 diabetes mellitus History of coronary artery disease congestive heart failure or significant valvular heart disease Known neurological disorders unrelated to diabetes eg stroke multiple sclerosis Parkinsons disease Patients with severe renal impairment eg eGFR less than 30 mLmin1.73 m Patients with severe hepatic dysfunction Presence of chronic alcohol use which can cause independent neuropathy Patients on medications known to affect autonomic function eg beta blockers certain antidepressants Active malignancy or current chemotherapy known to cause neuropathy eg platinum agents taxanes vinca alkaloids within the past 6 to 12 months Known hereditary neuropathy eg Charcot Marie Tooth or family history suggesting inherited neuropathy. Patients with history of chronic occupational or toxic exposure known to cause peripheral neuropathy eg heavy metals such as lead arsenic mercury Patients with Vitamin B12 deficiency Pregnant females

Design outcomes

Primary

MeasureTime frame
To determine the correlation between the severity of Diabetic Peripheral Neuropathy and the presence or severity of Cardiac Autonomic Neuropathy in patients with Type 2 Diabetes Mellitus at a single point of assessmentTimepoint: 3 Months

Secondary

MeasureTime frame
Prevalence of Cardiac Autonomic Neuropathy in patients with Diabetic Peripheral Neuropathy Association between duration of Type 2 Diabetes Mellitus and severity of Cardiac Autonomic NeuropathyTimepoint: 12 months

Countries

India

Contacts

Public ContactDr Kuchkar Snehal Sanjay

Vinayaka Missions Kirupananda Variyar Medical College and Hospital

mooks.stanlean@gmail.com9842459677

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026