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CTRI Number  CTRI/2019/01/016824 [Registered on: 01/01/2019] Trial Registered Prospectively
Last Modified On: 20/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   "THE STUDY TO EVALUATE THE REDUCED MUSCLE STRENGTH WITH QUALITY OF LIFE IN DIABETES MELLITUS”. 
Scientific Title of Study   “THE STUDY TO EVALUATE THE SUBCLINICAL LOWER EXTREMITY MUSCLE STRENGTH DECREASE IN DIABETIC INDIVIDUAL AND COMPARING WITH AGE MATCHED HEALTHY SUBJECTS INFLUENCING QUALITY OF LIFE”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenatchi N 
Designation  Post Graduate Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy,porur

Chennai
TAMIL NADU
600116
India 
Phone  919677109621  
Fax    
Email  meenubagyanb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  CM Radhika 
Designation  Asst.Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy

Chennai
TAMIL NADU
600116
India 
Phone  9841376961  
Fax    
Email  radhikashuba@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Meenatchi N 
Designation  Post Graduate Student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty of Physiotherapy

Chennai
TAMIL NADU
600116
India 
Phone  919677109621  
Fax    
Email  meenubagyanb@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 
 
Primary Sponsor  
Name  Meenatchi N 
Address  Sri Ramachandra Institute of higher education and Research, porur 
Type of Sponsor  Other [self] 
 
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 
Meenatchi N  Sri Ramachandra Medical Centre  diabetes and endocrinology department
Chennai
TAMIL NADU 
9677109621

meenubagyanb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Institute of Higher Education and Research- ETHICS COMMITTEE FOR STUDENTS PROJECTS  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  60.00 Year(s)
Gender  Both 
Details  Patient with type 2 DM with known duration and glycemic level and HbA1C levels (if available)
Cooperative and able to understand instruction.
Able to walk independently for 10metres, unaided
 
 
ExclusionCriteria 
Details  Cardiac and renal insufficiencies
muscular disorders/rheumatoid arthritis
foot ulcers/foot amputations
difficulty to perform activities of daily living
use of cane or any other equipment to get around
any neurological impairments
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
muscle strength evaluation for diabetic and comparing with normative healthy subjects -hand held dynamometer  With instruction of push hold for 3 sec and relax, for three join movements- knee extensors,ankle dorsiflexors and plantar flexors 
 
Secondary Outcome  
Outcome  TimePoints 
HbA1C levels, fasting and post prandial blood levels, age, BMI, gender  assessed during data analysis  
 
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)   02/01/2019 
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="18"
Months="4"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The main objective of this study is to determine whether a clinical scenario might exist where there will be a subclinical muscle power decrease without any reflections on functions performed in diabetic individuals when compared with age matched healthy individuals. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

   Diabetes mellitus is a chronic metabolic disease, characterized by hyperglycemia resulting in insulin secretion deficits, insulin action or both and highly glycated hemoglobin, higher in elderly than in younger population. Generally skeletal muscle tissue is responsible for 40% of body weight and considered as major site of insulin mediated glucose uptake, which accounts approximately 75% of whole body insulin stimulated glucose uptake  Therefore decrease in muscle strength especially in lower limbs is depicted by the insulin resistance, metabolic inflexibility and neuro muscular impairments.Earlier studies have stated that Diabetes mellitus is associated with loss of muscle strength in distal extremity of lower limb. There is a growing evidences which shows the complication of type 2 diabetes may translate into the functional impairment in older people, this might link the metabolic and mechanical function of the muscle

  Henceforth the evaluation of the lower extremity muscle strength can be assessed by hand held dynamometer, for knee extensors, ankle dorsiflexors, plantar flexors, in both diabetic and age matched healthy individuals, and to identify the impact of these muscles with sit to stand lower extremity functional strength and considering the variables like duration of diabetes, glycemic control, HbA1C values.

   Both the group will be evaluated with five repetition sit to stand test (FRSTST), to screen their lower extremity functional strength, and quality of life measure done through generic health related quality of life measure SF -36 Questionnaire

The main objective of this study is to determine whether a clinical scenario might exist where there will be a subclinical muscle power decrease without any reflections on functions performed in diabetic individuals when compared with age matched healthy individuals.

 
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