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 MELLITUSâ€. |
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 LIFEâ€. |
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
|
|
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
|
|
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 |
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. |