| CTRI Number |
CTRI/2023/03/050801 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
relationship of blood glucose levels with hands nerve study and hand grip strength in diabetes patients |
|
Scientific Title of Study
|
Association of blood glucose level with ncv in upper limb and handgrip strength in type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shraddha Jaybhaye |
| Designation |
MPT scholar |
| Affiliation |
parul institue of physiotherapy |
| Address |
3rd floor, Room no 308, Parul Institute Of Physiotherapy, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9764922263 |
| Fax |
|
| Email |
shraddha98jaybhaye@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Patel |
| Designation |
Assistant professor |
| Affiliation |
parul institue of physiotherapy |
| Address |
Room No 310, 3rd floor, Parul Institute Of Physiotherapy, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9601613569 |
| Fax |
|
| Email |
patel.dr.mansi08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Patel |
| Designation |
Assistant professor |
| Affiliation |
parul institue of physiotherapy |
| Address |
3rd Floor, Room No 310, Parul Institute Of Physiotherapy, Parul University, Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9601613569 |
| Fax |
|
| Email |
patel.dr.mansi08@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no 232, parul sevashram hospital, limda, waghodia-391760 |
|
|
Primary Sponsor
|
| Name |
Shraddha Jaybhaye |
| Address |
room no 308,parul institue of physiotherapy, parul university, limda, waghodia, vadodara |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shraddha Jaybhaye |
Parul Sevashram Hospital |
Room No 232,2nd floor,Parul Sevashram Hospital,Limda, Waghodia
Vadodara
GUJARAT |
9764922263
shraddha98jaybhaye@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Type 2 diabetes mellitus with lower limb neuropathy
2. Subjects between age group 45-60 years.
3. Both male and female.
4. On oral hypoglycemic medications only.
5. Without limitations of performing ADL’s.
|
|
| ExclusionCriteria |
| Details |
1. History of upper limb fracture within 6 months
2. Musculoskeletal disorder in upper limb.
3. Other neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
hand held dynamometer
|
2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| electromyographic equipment to measure NCV |
25 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/04/2023 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE: ASSOCIATION OF BLOOD GLUCOSE LEVEL WITH NCV IN UPPER LIMB , HAND GRIP STRENGTH IN TYPE 2 DIABETES MELLITUS AIM: · To associate blood glucose level with NCV in Upper limb and hand grip strength on type 2 diabetes mellitus OBJECTIVES: 1. To evaluate NCV in upper limb. 2. To evaluate hand grip strength. 3. To correlate blood glucose level with NCV in upper limb. 4. To correlate blood glucose level with hand grip strength. 5. To correlate NCV in upper limb with hand grip strength. |