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CTRI Number  CTRI/2025/03/082467 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Body fat distribution across different stages of diabetes 
Scientific Title of Study   Analysis of body fat distribution in different stages of diabetes  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S PREETHI 
Designation  Post Graduate 
Affiliation  Sri Ramachandra Institute Of Higher and Education Research 
Address  Physical rehabilitation centre, ground floor, new block OPD, Sri Ramachandra faculty of Physiotherapy, Sri Ramachandra Institute Of Higher and Education Research, no.01 Ramachandra nagar, Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9176242720  
Fax    
Email  preethivic2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sridevi S 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute Of Higher and Education Research 
Address  Physical rehabilitation centre, ground floor, new block OPD, Sri Ramachandra faculty of Physiotherapy, Sri Ramachandra Institute Of Higher and Education Research, no.01 Ramachandra nagar, Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9841401565  
Fax    
Email  devibsmoorthy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sridevi S 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute Of Higher and Education Research 
Address  Physical rehabilitation centre, ground floor, new block OPD, Sri Ramachandra faculty of Physiotherapy, Sri Ramachandra Institute Of Higher and Education Research, no.01 Ramachandra nagar, Porur Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9841401565  
Fax    
Email  devibsmoorthy@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra faculty of Physiotherapy, Sri Ramachandra Institute Of Higher and Education Research, no.01 Ramachandra nagar, Porur Chennai 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Preethi S  Sri Ramachandra Institute Of Higher Education and Research  Physical rehabilitation centre, ground floor, new block OPD, Sri Ramachandra faculty of Physiotherapy, Sri Ramachandra Institute Of Higher and Education Research, no.01 Ramachandra nagar, Porur Chennai
Chennai
TAMIL NADU 
9176242720

preethivic2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Institute of Higher Education Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diabetes Status Confirmed diagnosis of prediabetes or Type 2 diabetes
Willingness to undergo body composition analyzer

 
 
ExclusionCriteria 
Details  Individuals younger than 45 years or older than 65 years
Non Diabetic Status
Recent Weight Changes
Severe Co morbid Conditions
Medications Affecting Body Composition
Pregnancy or Lactation
Eating Disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Body composition analyzer  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Hand Grip Strength
Skin Fold Measurement
Glycemic control measures HbA1C
Balance test
6min walk test 
baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Participants for this study will be recruited from the Endocrinology Department at Sri Ramachandra Institute of Higher Education and Research (SRIHER). Each participant will be informed about the nature, procedures, and expected outcomes of the study, and written informed consent will be obtained prior to their inclusion.

 

Participant recruitment begins with identifying eligible individuals from the department and conducting preliminary screenings based on set criteria. Baseline data, such as demographics and clinical history, will be collected, followed by anthropometric measurements using standardized equipment. Body composition analysis will be performed using a bio-electrical impedance analyzer, ensuring participants adhere to per-assessment guidelines. Muscle strength will be measured using a hand dynamo-meter, with two trials for each hand, recording the highest value. Subcutaneous fat will be assessed with skin-fold calipers, averaging three measurements at specific anatomical sites, overall physical function will be evaluated using 6min walk test and  balance will be assessed using single leg balance test , with participants supported as needed for accuracy and completeness.

 

 
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