| CTRI Number |
CTRI/2025/09/095409 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of glycemic abnormalities, beta cell function and insulin sensitivity in transfusion dependent thalassemia patients : Cross sectional study. |
|
Scientific Title of Study
|
Study of glycemic abnormalities, beta cell function and insulin sensitivity in patients with transfusion dependent Thalassemia major : 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 |
DR POOJA PATIL |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
OPD number 8, Paediatrics OPD, KLE Prabhakar Kore Hospital, Nehru Nagar, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7760425009 |
| Fax |
|
| Email |
22pooja2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Jali |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845688999 |
| Fax |
|
| Email |
drsmjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Patil |
| Designation |
POST GRADUATE |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
OPD number 8, Paediatrics OPD, KLE Prabhakar Kore Hospital, Nehru Nagar, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7760425009 |
| Fax |
|
| Email |
22pooja2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR POOJA PATIL |
| Address |
Paediatric OPD number 8, KLE Prabhakar Kore Hospital, Nehru Nagar, Belgavi |
| 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 Pooja Patil |
Paediatrics OPD and Ward, KLE Prabhakar Kore Hospital, |
KLE Prabhakar Kore Hospital, Nehru Nagar
Belgaum
KARNATAKA |
7760425009
22pooja2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D561||Beta thalassemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
: Pediatric patients aged 1-18 years with transfusion dependent thalassemia with atleast 1 year since time of diagnosis who consent to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1. Known diabetic patients, those on insulin or oral hypoglycemic agents
2. Those with other significant systemic illnesses like cardiac failure, viral hepatitis, hepatocellular carcinoma and other neoplasias.
3. Those receiving hepatotoxic drugs
4. Those with syndromic illnesses
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of glycemic abnormalities |
Single assessment at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of beta cell function |
Single assessment at baseline |
| Assessment of insulin sensitivity/resistance |
Single assessment at baseline |
| Correlation of glycemic abnormalities and insulin resistance with serum ferritin levels |
Single assessment at baseline |
| Comparison of fructosamine levels with HbA1c for detection of glucose abnormalities |
Single assessment at baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2025 |
| 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
|
This cross-sectional observational study aims to evaluate glycemic abnormalities in paediatric patients with age group between 1 to 18 years with transfusion dependent thalassemia major attending a tertiary care hospital. The primary outcome will be prevalance and pattern of glycemic abnormalities in this population. Secondary outcomes include assessment of beta cell function, estimation of insulin resistance, correlation with serum ferritin levels, and comparison of fructosamine with HbA1c as markers of glucose metabolism. This study is expected to provide valuable insights into the burden and predictors of abnormal glucose regulation in thalassemia major and may help establish simple screening tools for early detection and prevention of diabetes in this high risk group. |