| CTRI Number |
CTRI/2025/09/095013 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of sugar Control on Platelet Parameters In Children And Adolescents With Type 1 Diabetes |
|
Scientific Title of Study
|
Effect of Glycemic Control on Platelet Parameters In Children And Adolescents With Type 1 Diabetes– A Case Control 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 Rakesh Gupta |
| Designation |
Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pediatrics
GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9850042002 |
| Fax |
|
| Email |
colrgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaleemullah |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Pediatrics
GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH
2012-310
India |
| Phone |
6386855260 |
| Fax |
|
| Email |
malikkaleem78.mk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaleemullah |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Pediatrics
GIMS Hospital
UTTAR PRADESH
2012-310
India |
| Phone |
6386855260 |
| Fax |
|
| Email |
malikkaleem78.mk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS)Kasna
Greater Noida
Gautam Buddha Nagar
Uttar Pradesh
Pin- 201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences Greater Noida |
| Address |
Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin- 201310 |
| Type of Sponsor |
Government medical college |
|
|
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 Kaleemullah |
Government Institute of Medical Sciences (GIMS) |
Room no. 19, Ground floor
Department of Pediatrics
Gautam Buddha Nagar
UTTAR PRADESH |
6386855260
malikkaleem78.mk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children and Adolescents(5-18yrs) diagnosed with T1DM with duration more
than 6 months, being followed up in the department of Pediatrics attending the
diabetic clinic will be included in the study
2. Patients who would be willing to give informed consent |
|
| ExclusionCriteria |
| Details |
• Children who are not diagnosed with Type 1 DM and are routinely visiting department of
Pediatrics for health checkups and other OPDs like Surgery/ ENT/ Ophthalmology for minor
procedures or follow up will be enrolled as control
• Patients who would be willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between glycemic control (HbA1c level) and
platelet parameters in children and adolescents with type 1 Diabetes Mellitus |
at the time of Enrollment day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare platelet parameters between children & adolescents with Type1
Diabetes Mellitus (cases) & age-matched healthy controls
• To evaluate the role of platelet parameters as early indicators of poor
glycemic control in pediatric Type 1 Diabetes Mellitus |
at the time of Enrollment day 1 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
16/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Type 1 diabetes mellitus (T1DM) is an autoimmune endocrine metabolic disorder. It
is caused by the destruction of pancreatic beta cells, triggered by genetic and
environmental factors. The incidence of Type 1 diabetes mellitus (T1DM) is
increasing day by day and associated with multiple complications in children and
adolescents due to its prothrombotic state [1]. As the onset of disease occurs in early
life, the affected group of individuals are at a great risk of developing cardiovascular
risk as a complication of diabetes. Over time, the various vascular complications
arise from hyperglycemia, dyslipidemia, inflammation, and oxidative stress and
depends on the duration of diabetes, level of metabolic control, and genetic factors.
Glycemic variability and long-term hyperglycemia contribute significantly to
increased morbidity and mortality.
T1DM is associated with altered metabolic environment which causes platelet
dysfunction and morphological changes, leading to thrombus formation and
increased risk of coronary and thromboembolic events [2]. In diabetic diseases,
changes in the levels of a wide range of haematological parameters function and
morphology have been highlighted in studies [3].
The complete blood count is a cheap and rapid test, and the hematological indices in
this test can be used to predict various vascular complications due to endothelial
dysfunction and inflammation. |