| CTRI Number |
CTRI/2025/09/095505 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study bone mineral density in Type 1 diabetes mellitus children |
|
Scientific Title of Study
|
Study of bone mineral density in children with Type 1 diabetes mellitus a one year cross sectional study in a
tertiary care hospital |
| 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 Yadiki Sai Tejeswar Reddy |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar
Belgaum
KARNATAKA
590001
India |
| Phone |
9703643753 |
| Fax |
|
| Email |
yadiki.tejesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata M Jali |
| Designation |
MBBS MD DCH Professor |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
Professor in Department of Paediatrics Jawaharlal Nehru Medical College Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9845688999 |
| Fax |
|
| Email |
drsmjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata M Jali |
| Designation |
MBBS MD DCH Professor |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi |
| Address |
Professor in Department of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9845688999 |
| Fax |
|
| Email |
drsmjali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Belagavi 590001 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Yadiki Sai Tejeswar Reddy |
| Address |
Department of Pediatrics Jawaharlal Nehru Medical College Belagavi 590001 Karnataka India |
| 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 Yadiki Sai Tejeswar Reddy |
KLES DR PRABHAKAR KORE HOSPITAL AND MRC |
Pediatrics Diabetes OPD No 8 Nehru Nagar BELAGAVI
Belgaum
KARNATAKA |
9703643753
yadiki.tejesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E108||Type 1 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children having Type 1 Diabetes Mellitus with diagnosis of more than 5 years of duration
|
|
| ExclusionCriteria |
| Details |
HISTORY OF VITAMIN D AND CALCUM SUPPLEMENTATION FOR MORE THAN 3 MONTHS
PARATHYROID DISORDERS
OBESE CHILDREN
CHILDREN ON DRUGS THAT AFFECT BONE MINERAL DENSITY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the bone mineral density in children with type 1 diabetes mellitus |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the bone mineral density with vitamin D levels in children with type 1 diabetes mellitus
2 To compare the bone mineral density with Parathyroid hormone levels in children with type 1 diabetes mellitus
3 To compare the bone mineral density with growth parameters in children with type 1 diabetes mellitus
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
15/10/2025 |
| 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 is a single-arm, cross-sectional observational study conducted over one year in a tertiary care hospital. The study will include children aged 5–18 years with Type 1 diabetes mellitus who meet inclusion criteria. Each participant will undergo clinical evaluation, anthropometry, pubertal staging, laboratory tests (PTH, calcium, vitamin D, etc.), and dual-energy X-ray absorptiometry (DXA) to assess bone mineral density (BMD). Data will be analyzed to estimate the prevalence of low BMD and to explore associations with clinical and biochemical factors such as age, sex, duration of diabetes, glycemic control, and nutritional status. |