| CTRI Number |
CTRI/2025/03/082501 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Utility of labile form of HbA1c in monitoring of patients with diabetes mellitus |
|
Scientific Title of Study
|
Exploring utility of Labile Glycated Hemoglobin in diabetic management: A comparative analysis with person’s glycemic status. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navya Gupta |
| Designation |
Medical Student |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Biochemistry, 2nd Floor, Academic Block, AIIMS, Village - Khanderi, Tehsil - Paddhari, District - Rajkot - Gujarat
Rajkot GUJARAT 360110 India |
| Phone |
7014021055 |
| Fax |
|
| Email |
navyaguptakg@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Navya Gupta |
| Designation |
Medical Student |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Biochemistry, 2nd Floor, Academic Block, AIIMS, Village - Khanderi, Tehsil - Paddhari, District - Rajkot - Gujarat
Rajkot GUJARAT 360110 India |
| Phone |
7014021055 |
| Fax |
|
| Email |
navyaguptakg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Navya Gupta |
| Designation |
Medical Student |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Department of Biochemistry, 2nd Floor, Academic Block, AIIMS, Village - Khanderi, Tehsil - Paddhari, District - Rajkot - Gujarat
Rajkot GUJARAT 360110 India |
| Phone |
7014021055 |
| Fax |
|
| Email |
navyaguptakg@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rajkot, Gujarat |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Rajkot |
| Address |
AIIMS Campus, Village - Khanderi, Tehsil - Paddhari, District - Rajkot (Gujarat) - 360110 |
| 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 |
| Navya Gupta |
All India Institute of Medical Sciences |
Ground Floor, Clinical Biochemistry Laboratory, All India Institute of Medical Sciences, Village - Khanderi, Tehsil - Paddhari, District - Rajkot Rajkot GUJARAT |
7014021055
navyaguptakg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z000||Encounter for general adult medical examination, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Labile HbA1c, Random Blood Glucose |
Labile HbA1c values generated from HPLC based A1c analysis and Random Blood Glucose values will be analysed for correlation. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Laboratory data of a total of 1000 patients attending out-patient department of AIIMS, Rajkot who are prescribed with HbA1c and random plasma glucose investigations will be included, irrespective of illness and ongoing treatment. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between random blood glucose and Labile HbA1c values |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variation in Stable and Labile HbA1c level in case of any hemoglobinopathies. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
27/03/2025 |
| 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="0" Months="11" 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
|
Diabetes mellitus is a major global public health concern among non-communicable diseases. Monitoring glycemic status is essential for managing diabetes, with glycated hemoglobin (HbA1c) being the most commonly used marker. HbA1c reflects average blood glucose over the preceding three months, but it responds slowly to changes in glucose metabolism. HbA1c formation involves non-enzymatic glycation, producing both a stable form (SA1c) and a reversible intermediate known as labile HbA1c (LA1c). LA1c reflects acute glucose fluctuations within the past few hours, making it a potential marker for short-term glycemic monitoring. Most HbA1c measurements focus only on the stable form, while LA1c is often overlooked. However, LA1c is not affected by red blood cell lifespan and can provide additional insights when SA1c and plasma glucose levels are contradictory. This study aims to evaluate the utility of LA1c in assessing current glycemic status. An observational cross-sectional study will be conducted on 1000 patients prescribed HbA1c and random plasma glucose tests. Data will be collected from automated analyzers and analyzed using SPSS software. Understanding the correlation between LA1c and glycemic status may improve short-term monitoring, assess treatment responses in newly diagnosed diabetics, and offer valuable insights in complex clinical scenarios where traditional markers fall short. |