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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details  None 
 
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.

 
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