| CTRI Number |
CTRI/2025/11/098077 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To check the effect of diabetes on the outcome of biological ageing on patients with diabetes mellitus |
|
Scientific Title of Study
|
Association of serum advanced glycation end product levels and sRAGE with biological ageing in patients of Type-2 diabetes mellitus |
| 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 Binita Goswami |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 256, Dept of Biochemistry, Pathology Block
New Delhi
DELHI
110002
India |
| Phone |
9810592004 |
| Fax |
|
| Email |
binita.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binita Goswami |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 256, Dept of Biochemistry, Pathology Block
New Delhi
DELHI
110002
India |
| Phone |
9810592004 |
| Fax |
|
| Email |
binita.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaideep Darkunde |
| Designation |
PG-I |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry, 2nd floor, Pathology Block
New Delhi
DELHI
110002
India |
| Phone |
9220876247 |
| Fax |
|
| Email |
drjaideep97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
India
110002 |
|
|
Primary Sponsor
|
| Name |
Department of Biochemistry |
| Address |
Maulana Azad Medical College, bahadur Shah Zafar Marg, New Delhi
India
110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Binita Goswami |
Department of Biochemistry, Maulana Azad Medical College, bahadur Shah Zafar Marg, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaideep Darkunde |
Lok Nayak hospital |
Room Number 316, Department of Medicine
and Clinical Biochemistry Lab, Department of Biochemistry
New Delhi
DELHI |
9220876247
drjaideep97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional EThics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cases
Patients with Type 2 Diabetes Mellitus (T2DM) according to ADA criteria
Patients with impaired glucose tolerance according to ADA criteria
Healthy controls |
|
| ExclusionCriteria |
| Details |
History of major mental stress
History of chronic hepatic disorder
Chronic renal failure
Chronic inflammatory disease
Cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To measure the serum levels of advanced glycation end products (AGE) and sRAGE in AGE matched diabetic subjects with euglycemic controls and subjects with impaired glucose tolerance.
2. To corelate the serum levels of AGE and sRAGE with the gap between the biological and chronological age in the study population. |
First 6 months sample collection
Next 6 months sample processing
Next 6 months data compilation and analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assist the markers of unfolded protein response with biological and chronological age between the case and controls. |
First 6 months sample collection
Next 6 months sample processing
Next 6 months data compilation and analysis |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Ageing is a time dependent decline in physiological organ function, increasing the risk of diseases like heart disease and cancer. Advanced glycation end products AGEs contribute not only as bio markers of aging and disease but also as causal agents in age-related metabolic diseases, including diabetes, neuro-degenerative conditions, and obesity. Thus, the source of AGEs are both endogenous and exogenous. Oxidative stress may be involved in AGE formation, and AGEs may induce oxidative stress. Accumulation of AGEs result in General Aging. AGEs may contribute to the decline in tissue and organ function with age, especially in age-related chronic disease. Cumulative damage to the genome as a result of Maillard and other non-enzymatic reactions is likely to be the primary determinant of species lifespan and health in old age. AGEs are not just markers of glycation but active mediators of metabolic and chronic diseases. |