| CTRI Number |
CTRI/2024/11/077185 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Metabolic Syndrome among Adolescents |
|
Scientific Title of Study
|
Metabolic Syndrome among Adolescents: A study of early detection with a Comprehensive Intervention to achieve improvement in Clinical, Biophysical, Anthropometric, and Metabolic markers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailaja Vijaykumar Mane |
| Designation |
Professor and HOD |
| Affiliation |
Department of Pediatrics, Dr D Y Patil Medical College Hospital and Research Centre Pune |
| Address |
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822595553 |
| Fax |
|
| Email |
shailaja.mane@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja Vijaykumar Mane |
| Designation |
Professor and HOD |
| Affiliation |
Department of Pediatrics, Dr D Y Patil Medical College Hospital and Research Centre Pune |
| Address |
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822595553 |
| Fax |
|
| Email |
shailaja.mane@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailaja Vijaykumar Mane |
| Designation |
Professor and HOD |
| Affiliation |
Department of Pediatrics, Dr D Y Patil Medical College Hospital and Research Centre Pune |
| Address |
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822595553 |
| Fax |
|
| Email |
shailaja.mane@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India-411018 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Medical College Hospital and research Centre Pune |
| Address |
Department of Pediatrics, Dr D Y Patil Medical College Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India-411018 |
| Type of Sponsor |
Other [private Medical College, Hospital and Research Institute] |
|
|
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 Shailaja Vijaykumar Mane |
Dr D Y Patil Medical College Hospital and Research Centre Pune |
Department of Pediatrics, Dr D Y Patil Medical College Hospital and Research Centre, Sant Tukaram nagar, Pimpri,Pune
Pune
MAHARASHTRA |
9822595553
shailaja.mane@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Dr D Y Patil Vidyapeeth Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening of adolescents for early detection and prevention of Metabolic Syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Intervention |
Continuous comprehensive intervention for 1 year will be implemented, including lifestyle modification, healthy diet plan, physical activity, sleep hygiene, and psychosocial support. Group sessions will be planned based on the data obtained from the proforma and assessment tools. A daily physical activity and exercise plan will be shared with the participants in the form of activity sheets, videos, and audio files. One-on-one sessions will be planned for the participants who have scored low on both measures. Tracking of these activities will be done by digital diary to maintain daily records of physical activity, diet, and sleep |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents 10 to 19 years of age. Healthy and apparently asymptomatic adolescents diagnosed with metabolic syndrome and willing to participate. |
|
| ExclusionCriteria |
| Details |
Adolescents having a chronic illness or any co-morbidity like congenital heart disease, renal failure, hemophilia, thalassemia, Type I Diabetes, etc. Adolescents who are receiving treatment such as steroids for any reason, thyroid hormones, antiepileptics, or any other medication. Adolescents with secondary causes of obesity (Endocrine, Syndromic ) and hypertension ( Renal, Adrenal, etc ) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This data will contribute to making health-related policies for adolescents and protocols for screening for early diagnosis and treatment of MetS. •A comprehensive health care model will encompass various levels of health care, which is necessary to achieve better management of MetS. •This comprehensive intervention in adolescents with MetS may help develop appropriate modules for extending it to the larger population. |
Screening, baseline, and post-intervention visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A comprehensive health care model will encompass various levels of health care which is necessary to achieve better management of Metabolic Syndrome |
Baseline visit, Comprehensive Intervention and Post-intervention visit |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
03/02/2025 |
| 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="3"
Months="0"
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
|
Metabolic syndrome (MetS) is linked with multiple disease states, and prevalence among adolescents is rising in tandem with obesity rates with increased risk of developing type 2 diabetes and cardiovascular disease in adulthood. Early detection and appropriate intervention are helpful in halting disease progression. These risk factors can be modifiable by appropriate lifestyle intervention and treatment. Globally, relatively very less interventional data is available. In India, interventional findings are scarce in adolescents with an early diagnosis of MetS. This study will explore the effect of early detection and comprehensive intervention on the clinical, anthropometric, metabolic, and inflammatory status of adolescents with MetS. Objectives-To assess the effect of early detection, and comprehensive intervention on Clinical, biophysical, and anthropometric parameters, and Metabolic, inflammatory, and adiposity markers in adolescents with metabolic syndrome. Methods- This will be an interventional study on adolescents (10-19Yrs). Obese and overweight adolescents will be screened from Public and Private Secondary schools and Junior colleges. Eligible and willing participants will be enrolled for the detection of MetS and comprehensive intervention for 1year. Their baseline, intermediate (6 months), and post-intervention assessment of clinical, biophysical, and anthropometric parameters will be done. Baseline and post-intervention metabolic, inflammatory, and adiposity markers will be analyzed and compared to assess the effect of the intervention. Outcome- Improvement in clinical signs, significant change in behavioral and psychological aspects as well as metabolic, inflammatory, and adiposity status. With the above findings, a comprehensive intervention model will be helpful for treating and managing Mets in adolescence.
Hypothesis- Can early identification and comprehensive intervention in adolescents with metabolic syndrome help to improve clinical, biophysical, anthropometric, metabolic, inflammatory, and adiposity markers?
|