CTRI Number |
CTRI/2023/06/054475 [Registered on: 27/06/2023] Trial Registered Prospectively |
Last Modified On: |
21/06/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Prospective observation study |
Study Design |
Other |
Public Title of Study
|
To Assess hand grip strength in patients with type 2 diabetes |
Scientific Title of Study
|
Prospective study of hand grip strength in patients with type 2 diabetes |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr ANOOP MISRA |
Designation |
Chairman |
Affiliation |
Fortis CDOC Hospital |
Address |
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
Room No 1, Diabetes and Endocrine department
South DELHI 110048 India |
Phone |
01149101222 |
Fax |
|
Email |
anoopmisra@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr ANOOP MISRA |
Designation |
Chairman |
Affiliation |
Fortis CDOC Hospital |
Address |
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
Room No 1, Diabetes and Endocrine department
South DELHI 110048 India |
Phone |
01149101222 |
Fax |
|
Email |
anoopmisra@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr ANOOP MISRA |
Designation |
Chairman |
Affiliation |
Fortis CDOC Hospital |
Address |
B-16 Chirag Enclave Opp Devika Tower, Nehru Place
Room No 1, Diabetes and Endocrine department
South DELHI 110048 India |
Phone |
01149101222 |
Fax |
|
Email |
anoopmisra@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [NA] |
|
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 |
Juhi Mittal |
Fortis CDOC Hospital |
B-16 Chirag Enclave Opp Devika Tower, Nehru Place Room No 15 South DELHI |
01149101222
jmittal83@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ETHICS COMMITTEE FOR RESEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
50.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Patients with Type 2 diabetes |
|
ExclusionCriteria |
Details |
1.Chronic alcohol intake
2.Thyroid dysfunction
3.Any musculoskeletal condition causing difficulty in holding the dynamometer |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To as certain the effect of randomized control trial in intensive v/s usual education group for intervention for sarcopenia. |
12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To review effects as of intensive intervention on HbA1c levels |
12 months |
|
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)
|
15/07/2023 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Background: Diabetes has been a major global health concern since past few decades. According to The
International Diabetes Federation (IDF), “global prevalence of diabetes is around 9.3 %( 2019)
and will rise to 10.95 by 2045 (1). There are estimated 72.96 million cases of diabetes in adult
population of India. (2) Asians are more prone to have diabetes and associated metabolic
disorders as compared to Caucasians.
Nowadays, it is seen that diabetes is not limited to patients with obesity; in fact, it is increasingly
penetrating into the population having low to normal BMI. Research studies show that resistance
training is an effective and important lifestyle modification that helps to improve overall
metabolic function and reduce metabolic risk factors in diabetic patients. (3) The fat-to-muscle
ratio is independently and positively associated with metabolic disorders in T2DM. Fat-tomuscle ratio may serve as an optimal method for screening T2DM patients coupled with a high
risk of abnormal metabolism, especially in females. (4).
Study shows that grip strength was negatively correlated with blood hemoglobin A1c (HbA1c)
levels. It is seen that the diabetic patients have a lower grip strength as compared to non-diabetic
patients of the same age group. (5)
Now, in this study we will study the development of hand grip strength in type 2 diabetic patients
who engage in regular physical activity.
Methodology:
We shall compare the difference between hand grip strength at every follow up (3 to 6 months)
for patients with diabetes.
1. The following anthropometric measurements will be recorded: height, weight, waist
circumference, hip circumference, and body mass index.
2. We will measure the hand grip strength for all the patients. Measurement of maximal grip
strength will be performed using Jamar dynamometers, which estimate the muscle
strength primarily generated by the flexor muscles of the hand and the forearm. The
Jamar displays grip force in both pounds and kilograms, with a maximum of 200 lb
(90 kg). It has a peak-hold needle that automatically retains the highest reading until
reset. The Jamar test is isometric, with no perceptible motion of the handle, regardless of
the grip strength applied. The participants will be encouraged to produce their maximal
grip strength. Three trials will be recorded, consisting of a 2-4-second maximal
contraction, with a 30-second rest period between each trial. The average of the three
readings will be taken for both the patient groups.
3. All the subjects will be given a resistance exercise protocol and compliance will be
checked at every follow up. |