| CTRI Number |
CTRI/2024/12/078180 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Metabolic syndrome in urban youth and the effectiveness of life style modifications-a study in a town in Andhra Pradesh |
|
Scientific Title of Study
|
Prevalence of Metabolic Syndrome Among Urban Youth
Aged 15-29 Years and effectiveness of life style modifications: A
pre-post interventional study in a town in Andhra Pradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreelakshmi Muralikrishnan |
| Designation |
Post graduate student |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of community and family medicine third floor medical college building AIIMS Mangalagiri Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9995792410 |
| Fax |
|
| Email |
sreelakshmi91098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sathiyanarayanan S |
| Designation |
Associate professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of community and family medicine third floor medical college building AIIMS Mangalagiri Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9597339969 |
| Fax |
|
| Email |
sathiya@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sreelakshmi Muralikrishnan |
| Designation |
Post graduate student |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of community and family medicine third floor medical college building AIIMS Mangalagiri Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9995792410 |
| Fax |
|
| Email |
sreelakshmi91098@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sreelakshmi Muralikrishnan |
| Address |
Department of community and family medicine third floor medical college building AIIMS Mangalagiri Guntur Andhra Pradesh India PIN 522503 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sathiyanarayanan S |
Associate professor department of community and family medicine AIIMS Mangalagiri |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreelakshmi Muralikrishnan |
AIIMS Mangalagiri Urban health training centre |
Department of community and family medicine room 302 third floor medical college building AIIMS Mangalagiri PIN 522503
Guntur
ANDHRA PRADESH |
9995792410
sreelakshmi91098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
volunteers between age 18-29 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Life style modification advice |
Lifestyle modification advice will be given as per recommendations in National health mission(NHM) standard treatment guidelines for hypertension, ICMR guidelines for management of type 2 diabetes mellitus and Consensus statement on management of dyslipidemia in Indian subjects these will have dietary advices, physical activity recommendations and other life style modifications with twice a month reinforcements. this will continue for 6 months after baseline assessment |
| Comparator Agent |
Not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
persons of all genders 15-29 years residing in Mangalagiri-Tadepalli municipal corporation |
|
| ExclusionCriteria |
| Details |
Pregnant women ,Bedridden persons,persons with acute illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in abnormal parameters(Fasting blood glucose Fasting serum triglyceride Hip circumference Serum HDL Blood pressure |
Change in abnormal parameters(Fasting blood glucose Fasting serum triglyceride Hip circumference Serum HDL Blood pressure from baseline to after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barriers in implementing the life style modifications |
6 months |
|
|
Target Sample Size
|
Total Sample Size="541"
Sample Size from India="541"
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)
|
01/01/2025 |
| 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 Yet Recruiting |
| 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
|
Metabolic syndrome is becoming increasingly prevalant among youth. As
the risk factors of metabolic syndrome begin at an early age, we are interested to
study the prevalence of Metabolic Syndrome among youth(15-29 years) in urban area and the associated sociobehavioral factors. Out of those participants who are diagnosed with Metabolic syndrome according to NCEP ATP III criteria,following blood tests for fasting blood glucose, fasting serum triglyceride, serum HDL, waist circumference and blood pressure lifestyle modification advice will be given as per standard guidelines bu NHM, ICMR for lifestyle changes in diabetes and Hypertension as per the abnormal parameters in the participants. They will be followed up after 6 months and any change in the parameters will be assessed and the barriers for implementing the lifestyle changes will be assessed. |