| CTRI Number |
CTRI/2025/03/083045 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of Diabetes Duration With Nerve conduction |
|
Scientific Title of Study
|
Association of Duration of Disease with Diabetic Distress AND Nerve Conduction Velocity in Type 2 Diabetes Mellitus A cross sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
professor |
| Affiliation |
centre for physiotherapy and Rehabiliation sciences Jamila Millia Islamia |
| Address |
Room No 105 ist floor
centre for physiotherapy and Rehabiliation sciences
Jamila Millia Islamia
Mohammad ali Marg Jamia Nagar New delhi 110025
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
professor |
| Affiliation |
centre for physiotherapy and Rehabiliation sciences Jamila Millia Islamia |
| Address |
Room No 105 ist floor
centre for physiotherapy and Rehabiliation sciences
Jamila Millia Islamia
Mohammad ali Marg Jamia Nagar New delhi 110025
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Noor Jahan |
| Designation |
post graduate |
| Affiliation |
centre for physiotherapy and Rehabiliation sciences Jamila Millia Islamia |
| Address |
Room No 208 second floor centre for physiotherapy and Rehabiliation sciences
Jamila Millia Islamia
Mohammad ali Marg
Jamia Nagar New delhi 110025
South
DELHI
110025
India |
| Phone |
8700235298 |
| Fax |
|
| Email |
noor98739@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamila Millia Islamia Mohammad ali Marg Jamia Nagar
New delhi 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia millia islamia |
| Address |
Jamaia Nagar okhla vihar New delhi 110025 |
| Type of Sponsor |
Other [Central university] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| professor Majumi m Noohu |
jamia millia islamia |
PHD lab ground floor Centre for physiotherapy and rehabiliation sciences New delhi 110025
South
DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee Jamia Millia islamia New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Medically Diagnosed cases of diabetes Mellitus
Age 45+ years
Both genders
Duration of diabetes less than 10 years (neuropathy starts to develop after 10 years of disease duration).
|
|
| ExclusionCriteria |
| Details |
1 Considered abnormal) ( Muntean, C., 2016).
2 Any neuropathy other than the cause of diabetes like alcohol renal failure, malnutrition.
3 Neuropathies associated with exogenous toxins metals or drugs
4 Any neuromuscular conditions that affect the nerve conduction velocity like myopathy, familial polyneuropathy, or chronic polyneuropathy, GBS.
Any history of trauma in upper limb and lower limb in the recent years.
Skin lesions that can affect the nerve conduction recordings
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nerve Conduction Velocity Latency,Amplitude,Diabetic distress well being quality of life |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be performed at center for physiotherapy and Rehabiliation sciences at PHD lab in ground floor they will be called as flyers and a word of mouth. the subject will be told their rights as subject will be screened by using MNSI (Michigan neuropathy screening instrument) questionaire and then asked to fill the DDS (Diabetic distress scale ) qustionaire and Well being quesionaire with the help of the examinar they will be told the procedure of the NCV and the area which is being tested the recording electrode should be placed on the respective areas including the upper and lower limb nerves ( Radial,Ulnar,Median) lower limb nerves (Tibial,Sural,Superficial peroneal ) respectively. |