| CTRI Number |
CTRI/2026/03/106913 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate muscle mass with a body composition analysis machine in young adults, less than and equal to 40 with first time detected diabetes and changes in muscle mass after 6 month of treatment,include standard diabetic oral drugs. |
|
Scientific Title of Study
|
Prevalence of Sarcopenia in young adults with newly diagnosed type 2 Diabetes and the influence of initial treatment on body composition and muscle health. A hospital based prospective cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyank kumar singh |
| Designation |
junior resident |
| Affiliation |
All india institute of medical sciences, rajkot, gujarat |
| Address |
2nd floor. medicine opd, ipd building,aiims rajkot
room 2-BCA room, 1st floor,department of physiology aiims rajkot.
Rajkot
GUJARAT
360006
India |
| Phone |
09935358072 |
| Fax |
|
| Email |
tn.an.aaaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
komal kumar jangir |
| Designation |
assistant prof. |
| Affiliation |
All india institute of medical sciences, rajkot, gujarat |
| Address |
2nd floor medicine opd ,ipd building, Aiims rajkot.
1st floor, bma lab, department of physiology,academic building, aiims rajkot.
Rajkot
GUJARAT
360006
India |
| Phone |
8302458006 |
| Fax |
|
| Email |
komal.jangir3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyank kumar singh |
| Designation |
junior resident |
| Affiliation |
All india institute of medical sciences, rajkot, gujarat |
| Address |
2nd floor, medicine opd,ipd building, Aiims rajkot
1st floor, bma lab, department of physiology,academic building, aiims rajkot
Rajkot
GUJARAT
360006
India |
| Phone |
09935358072 |
| Fax |
|
| Email |
tn.an.aaaa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Rajkot, Gujarat |
| Address |
All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
|
| Type of Sponsor |
Government medical college |
|
|
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 |
| Priyank kumar singh |
All India Institute of medical sciences, rajkot. |
2nd floor, medicine opd, ipd building department of general medicine. 1st floor,bma room department of physiology,academic building.
Rajkot
GUJARAT |
9935358072
tn.an.aaaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), All India Institute of Medical Sciences(AIIMS), Rajkot |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged less than 40 years, newly diagnosed with type 2 Diabetes (HbA1c equal or more than 6.5% or fasting glucose equal or more than 126 mg/dL), no prior diabetes treatment or minimal treatment (less than 1 month), and willing to undergo body composition analysis. |
|
| ExclusionCriteria |
| Details |
Type 1 diabetes, secondary diabetes, severe comorbidities(like cancer, end-stage renal disease),
pregnancy, conditions contraindicating body composition testing or who require insulin therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in skeletal muscle mass and segmental lean mass from baseline to 6 months, measured using InBody 770, Dynamometer in newly diagnosed Diabetes mellitus, Also calculate the prevalence of sarcopenia. |
Baseline(0 month) and at end of study(6 month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between changes in skeletal muscle mass and glycemic control(HbA1c) over 6 month. prevalence and severity of sarcopenia at baseline and 6 months(using muscle mass, handgrip strength and gait speed). change in phase angle from baseline to 6 months. Change in body composition parameters(body fat%, visceral fat, extracellular water ratio) from baseline to 6 months. |
Baseline(0 month) and at end of study(6 month) |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
06/04/2026 |
| 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="6"
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
|
My study is a prospective observational study which aims to evaluate changes in skeletal muscle mass and body composition in patients with newly diagnosed type 2 diabetes mellitus over a period of 6 months. Sarcopenia is increasingly recognized as an important comorbidity in patients with diabetes mellitus and is associated with poor glycemic control and adverse clinical outcomes. Young adults patients(upto 40 yrs) with type 2 diabetes mellitus attending medicine opd of aiims rajkot will be included. baseline assessment will include measurement of skeletal muscle mass, phase angle, and other body composition parameters using bioelectrical impedence analysis(InBody 770). glycemic control will be assessed using HbA1c levels, and functional assessment will include handgrip strength and gait speed. participants will be followed up at 6 months, and changes in muscle mass, body composition parameters, and phase angle will be reassessed. the study will also evaluate prevalence and severity of sarcopenia and its association with glycemic control. findings may help in early identification and management of sarcopenia in patients with type 2 diabetes mellitus and improvement in muscle mass will also decrease in insulin resistance leading to overall better outcome. |