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A study in the participants with type 2 diabetes mellitus using a simple sweat conductance test, with main outcome being early identification of diabetic nerve damage.

Utility of evaluating sudomotor function by sudoscan for early identification of diabetic peripheral neuropathy in patients with type 2 diabetes mellitus - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/102389
Enrollment
96
Registered
2026-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Dr. Priyamvada Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Individuals with age more than 18 years with type 2 diabetes mellitus as per the ADA criteria 2.Patients on treatment for type 2 diabetes mellitus.

Exclusion criteria

Exclusion criteria: 1.Individuals less than 18 years or above 80 years. 2.Clinical evidence of peripheral vascular disease ( absent peripheral pulses, skin changes, gangrene and symptoms of claudication). 3.Patients who have received chemotherapy in the past. 4.Patients with history of smoking more than or equal to 10 pack years. 5.Alcohol use disorder diagnosed as per the CAGE questionnaire. 6.Any known underlying autoimmune disorder. 7.HBV, HCV or HIV serology positive. 8.Patients with history of amputation. 9.Patients on drugs affecting sympathetic activity (such as clonidine, amphetamines, beta blockers, beta 2 agonists, alpha blockers, beta 3 adrenergic agonists) daily intake for a duration of 5-10 years.

Design outcomes

Primary

MeasureTime frame
To study the efficacy of Sudoscan in detecting early small fibre neuropathy in diabetic patients grouped as having the disease for less than and more than or equal to 5 yearsTimepoint: Baseline (at the time of participant enrollment) single time assesment only.

Secondary

MeasureTime frame
The secondary outcome measure will also be to compare the results with the standard NCS. The results will then be compared with the clinical assessment using the MNSI.Timepoint: Baseline (at the time of participant enrollment) single time assesment only.

Countries

India

Contacts

Public ContactDr Priyamvada Singh

Kasturba Medical college, Manipal

aparna.pai@manipal.edu9880182224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026