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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  
NA 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
 
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