| CTRI Number |
CTRI/2026/02/104141 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study Serum Adiponectin As Biomarker For Insulin Resistance In Newly Diagnosed Type 2 Diabetes |
|
Scientific Title of Study
|
Serum Adiponectin Levels as a Biomarker for Insulin Resistance in Newly Diagnosed Type 2 Diabetes Mellitus patients: A Cross-Sectional 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 |
Manan patel |
| Designation |
PG student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
DEPARTMENT OF GENERAL MEDICINE JAWAHARLAL NEHRU MEDICAL COLLEGE BELAGAVI - 590010 KARNATAKA
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9518916878 |
| Fax |
|
| Email |
Mananpatel510.mp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arif Maldar |
| Designation |
Professor/medical superintendent |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Medicine Jawaharlal Nehru Medical College
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
08312471350 |
| Fax |
|
| Email |
arifmaldar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manan Prakash Patel |
| Designation |
PG Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Medicine
Jawaharlal Nehru Medical College Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9518916878 |
| Fax |
|
| Email |
mananpatel510.mp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manan Patel |
| Address |
Department Of General Medicine Jawaharlal Nehru Medical College, Belagavi
– 590010 Karnataka, India
Belgaum
KARNATAKA |
| 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 |
| Dr Manan Patel |
Dr KLE Prabhakar Kore hospital |
Department Of General Medicine Jawaharlal Nehru Medical College, Belagavi
– 590010 Karnataka, India
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9518916878
Mananpatel510.mp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients of either sex with age more than 18 years willing to participate in the study,
individuals with recent onset type 2 diabetes mellitus,
hba1c levels more than 6.5
|
|
| ExclusionCriteria |
| Details |
subjects on insulin therapy or oral hypoglycemic agents, subjects with chronic illnesses like Chronic kidney disease,heart failure or Chronic liver disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess serum adiponectin levels in newly diagnosed type 2 Diabetes Mellitus patients |
Serum adiponectin levels at the time of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to correlate adiponectin levels with insulin resistance markers like HOMA-IR, fasting insulin & fasting glucose
|
Fasting insulin levels at day 1 of admission
Fasting glucose levels at day 1 of admission |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/03/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to address this gap by investigating serum adiponectin levels specifically in newly diagnosed T2DM patients, excluding those on pharmacologic therapy or with chronic illnesses that could influence metabolic parameters. By correlating adiponectin levels with markers of insulin resistance such as HOMA-IR, fasting glucose, and fasting insulin, we seek to evaluate its utility as a cost-effective and early biomarker for insulin resistance. Such findings could significantly contribute to the stratification and early detection of at-risk individuals, ultimately informing targeted prevention strategies in the Indian clinical context.
|