| CTRI Number |
CTRI/2025/11/097326 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Overweight and Health Issues in Children With Kidney Disease |
|
Scientific Title of Study
|
Obesity and Its Associated Co-morbidities in Children With Nephrotic Syndrome: A Cross-sectional 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 |
PUTTARAJ MUDAGAL |
| Designation |
PG RESIDENT MD PAEDIATRICS |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College KLE Academy of HigherEducation And Research Center Nehru Nagar Belagavi Karnataka 590010
Department of Paediatrics JNMC Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9591924893 |
| Fax |
|
| Email |
puttu830@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh v patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College KLE Academy of Higher Education And Research Center Nehru Nagar Belagavi Karnataka 590010
Department Of Paediatrics Nephrology JNMC belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9483561674 |
| Fax |
|
| Email |
drmahanteshvpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PUTTARAJ MUDAGAL |
| Designation |
PG RESIDENT MD PAEDIATRICS |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College KLE Academy of Higher Education And Research Center Nehru Nagar Belagavi Karnataka 590010
Department of Paediatrics JNMC Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9591924893 |
| Fax |
|
| Email |
puttu830@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College
Nehru Nagar, KLE Hospital Road, Belagavi 590010
Karnataka State
India |
|
|
Primary Sponsor
|
| Name |
PUTTARAJ MUDAGAL |
| Address |
Department of Paediatrics,Jawaharlal Nehru Medical college Nehru Nagar Belagavi karnataka,590010 |
| Type of Sponsor |
Other [SELF] |
|
|
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 PUTTARAJ MUDAGAL |
JAWAHARLAL NEHRU MEDICAL COLLEGE BELAGAVI |
Jawaharlal Nehru Medical College KLE academy of higher education And research center Nehru Nagar Belagavi Karnataka 590010
Department of paediatrics jnmc belagavi
Belgaum
KARNATAKA |
9591924893
puttu830@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Ethical Institutional Committee Jawaharlal Nehru Medical College, Nehru Nagar , Belagavi -590010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, (2) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. 1-18year-old children with nephrotic syndrome |
|
| ExclusionCriteria |
| Details |
1. children with first episode of nephrotic syndrome
2. children with secondary causes of nephrotic syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the prevalence of obesity and overweight in children with nephrotic syndrome
2.To analyse short stature among nephrotic syndrome patients
3.To estimate the prevalence of diabetes mellitus in these children |
50weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To analyse short stature among nephrotic syndrome patients
2.To estimate the prevalence of diabetes mellitus in these children |
50weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
22/11/2025 |
| 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="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
|
Obesity in this population not only increases the risk for cardiovascular comorbidities such as hypertension and dyslipidaemia, but it may also influence the course of NS by contributing to more frequent relapses, reducing steroid responsiveness, and increasing the likelihood of progression to chronic kidney disease (CKD). (6) Long-term corticosteroid therapy, commonly used in NS management, exacerbates these risks by impairing glucose metabolism, promoting hepatic gluconeogenesis. The co-existence of obesity, NS, and corticosteroid therapy thus creates a metabolic environment to the development of diabetes mellitus. (7) Despite increasing awareness of the complex interplay between nephrotic syndrome, obesity, and diabetes mellitus in children, existing literature remains limited, with most studies focusing on adult populations or exploring these conditions in isolation. (8) |