| CTRI Number |
CTRI/2025/05/086668 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Hand Grip Strength Relates to Blood Sugar Control in People with Type 2 Diabetes |
|
Scientific Title of Study
|
Correlation Between Hand Grip Strength and Glycemic Control Amongst Chronic Type 2 Diabetes Mellitus Population
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nistha Mishra |
| Designation |
Post Graduate Student |
| Affiliation |
SRM College Of Physiotherapy, SRM Institute Of Science and Technology |
| Address |
Room no PT 22, 4th floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8114881718 |
| Fax |
|
| Email |
nm5410@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. T S Veeragoudhaman |
| Designation |
Dean |
| Affiliation |
SRM College Of Physiotherapy, SRM Institute Of Science and Technology |
| Address |
5th floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9500375408 |
| Fax |
|
| Email |
veeragot@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nistha Mishra |
| Designation |
Post Graduate Student |
| Affiliation |
SRM College Of Physiotherapy, SRM Institute Of Science and Technology |
| Address |
Room no PT 22, 4th floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8114881718 |
| Fax |
|
| Email |
nm5410@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM college of physiotherapy SRM institute of science and technology SRM nagar Potheri Kattankulathur Tamil Nadu 603203 India |
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room no PT 22, 4th floor,SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr T S Veeragoudhaman PT |
SRM Medical College and Research Centre |
General Medicine Department, 1st floor, SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur, Tamil Nadu 603203, India
Chennai
TAMIL NADU |
9500375408
veeragot@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants of all genders will be included
Adults aged 18 and above will be included in study, who volunteer to participate in the study.
Diagnosed chronic type 2 diabetes mellitus adults.
Participants who are able to hold hand dynamometer.
|
|
| ExclusionCriteria |
| Details |
Visually impaired
Cognitively impaired
Any painful conditions in upper extremity
Any palmar skin diseases
Neuromuscular condition that affect the hand grip strength
Burns or scars in the palm region
Participants on religious fasting period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measures:
Hand Dynamometer : Hand grip strength
The haemoglobin A1c test : Level of glucose control
|
One time assessemnt
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome Measure:
Height
Weight
BMI |
One time assessment |
|
|
Target Sample Size
|
Total Sample Size="193"
Sample Size from India="193"
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)
|
05/06/2025 |
| 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="8"
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
|
•Need the study: Diabetes Mellitus (T2DM) continues to rise globally, with
chronic hyperglycemia leading to significant complications. While glycemic
control remains a primary focus in diabetes management, there is growing
evidence that physical strength, particularly hand grip strength, may be
associated with metabolic health. Hand grip strength is a simple, non-invasive
measure that reflects overall muscle function, which could potentially serve as
a marker for glycemic control. However, the relationship between hand grip
strength and glycemic control in the chronic T2DM population remains
underexplored. This observational study aims to fill this gap by assessing
whether lower hand grip strength correlates with poorer glycemic control in
individuals with T2DM. Understanding this relationship could provide new
insights into how physical strength relates to diabetes outcomes and
complications. Additionally, it could lead to more effective screening
strategies and interventions for improving diabetes management. Ultimately,
this study could contribute to better patient outcomes by emphasizing the
importance of muscle health in chronic disease management. •AIM:
To evaluate the relationship
between the hand grip strength and the glycemic control, as determined with the
help of Haemoglobin
A1c (HbA1c) test and hand dynamometer, in adults aged 18 and above with
chronic Type 2 Diabetes Mellitus (T2DM). |