| CTRI Number |
CTRI/2025/11/097305 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring metabolic proteins in key signaling pathways in Type 2 diabetes |
|
Scientific Title of Study
|
A Cross-Sectional Study to Explore Metabolic Proteins in the PI3K/AKT and cAMP/PKA Signaling Pathways in Type 2 Diabetes Mellitus Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Nilanjan Saha |
| Designation |
Professor and Head |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard - 110062
New Delhi
DELHI
110062
India |
| Phone |
9873013366 |
| Fax |
|
| Email |
nilanjan.saha@jamiahamdard.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Zoya Khan |
| Designation |
Ph.D. Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard - 110062
New Delhi
DELHI
110062
India |
| Phone |
7518007282 |
| Fax |
|
| Email |
zoyalam02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zoya Khan |
| Designation |
Ph.D. Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard - 110062
New Delhi
DELHI
110062
India |
| Phone |
7518007282 |
| Fax |
|
| Email |
zoyalam02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard
Hamdard Nagar,
New Delhi, Delhi 110062,
India |
|
|
Primary Sponsor
|
| Name |
Prof Nilanjan Saha |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard - 110062 |
| 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 |
| Prof Dr Nilanjan Saha |
Batra Hospital & Medical Reseach Centre |
Room No. G-16, Department of Internal Medicine, Block A.
New Delhi
DELHI |
09873013366
nilanjan.saha@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
| Scientific Research & Ethical Review Committee (SRERC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers (HbA1c 5.7%, normal glucose tolerance) |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Venous blood sample |
5 mL of blood will be collected from each participant for biomarker analysis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Controls
Age between 18 and 65 years
Both Male and Female
HbA1c less than 5.7 percent based on ADA diagnostic criteria for normal glucose tolerance.
No history of acute or chronic infections, inflammatory diseases, or malignancy.
Not currently taking medications known to affect glucose metabolism, lipid profile, or inflammatory markers.
Willing to provide written informed consent
Pre-diabetes
Age between 18 and 65 years
Both Male and female
HbA1c between 5.7 and 6.4 percent
No prior diagnosis of diabetes mellitus
No ongoing antidiabetic treatment
Free from chronic illnesses such as renal, hepatic, cardiac, or autoimmune diseases.
Willing to provide written informed consent
T2DM
Age between 18 and 65 years
Both Male and female
HbA1c equal to or more than 6.5 percent as per ADA criteria or patient taking OHAs
Stable clinical condition without history of diabetic ketoacidosis, hyperosmolar hyperglycemic state, or recent hospitalization (within last 3 months).
Not on medications that could affect study biomarkers, except for prescribed antidiabetic drugs and routine medications for controlled comorbidities.
Participants willing to provide written informed consent and adhere to study protocols.
|
|
| ExclusionCriteria |
| Details |
Age below 18 years or above 65 years
Pregnant or lactating women
History of type 1 diabetes, gestational diabetes, or secondary diabetes
Presence of chronic systemic illness (renal failure, advanced liver disease, heart failure, autoimmune disorders, malignancy)
Acute infection or hospitalization in last three months
Current use of medicines that significantly alter glucose metabolism, lipid profile, or inflammatory markers (other than prescribed oral antidiabetic drugs)
Inability or unwillingness to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum levels of GP73, FAM3A, ASGR1, and GPHB5 measured by ELISA in Healthy, Prediabetes, and Type 2 Diabetes Mellitus groups.
Correlation of serum GP73, FAM3A, ASGR1, and GPHB5 with key glycemic parameters (HbA1c, fasting plasma glucose).
|
There will be a single assessment at baseline (at the time of enrollment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of serum GP73, FAM3A, ASGR1, & GPHB5 with inflammatory markers (IL-1B, IL-10).
Comparison of biomarker levels (GP73, FAM3A, ASGR1, GPHB5) across demographic subgroups (age, sex, BMI). |
The assessment will be conducted only once at baseline. |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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)
|
01/12/2025 |
| 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 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
|
This cross-sectional study will quantify serum GP73, GPHB5, FAM3A and ASGR1 at one baseline visit in adults classified as healthy controls, prediabetes and type 2 diabetes mellitus, and examine their relationships with glycaemic control (glycated haemoglobin and fasting plasma glucose), indices of insulin resistance and beta-cell function (HOMA IR and HOMA Beta), inflammatory markers (IL-1B, IL-10). The study hypothesis is that GP73, GPHB5 and ASGR1 are higher in prediabetes and type 2 diabetes than in healthy controls and are positively associated with poorer glycaemic control, greater insulin resistance and higher inflammatory activity, whereas FAM3A is lower and inversely associated with these parameters. |