| 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
|
|
|
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
|
|
|
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.
|