| CTRI Number |
CTRI/2025/09/095356 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
TYPE2 DIABETICS AND INSULIN RESISTANCE |
|
Scientific Title of Study
|
Correlation of leptin with insulin resistance in normal, overweight and obese Type 2 diabetic 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 |
Gayatri Suneja |
| Designation |
Junior Resident |
| Affiliation |
KMC Manipal |
| Address |
Department of General Medicine
KMC Hospital
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9996438300 |
| Fax |
|
| Email |
gayatrisuneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Cynthia Amrutha |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of General Medicine
KMC Hospital
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7259415415 |
| Fax |
|
| Email |
cynthia.amrutha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cynthia Amrutha |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of General Medicine
KMC Hospital
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7259415415 |
| Fax |
|
| Email |
cynthia.amrutha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE, MANIPAL UNIVERSITY, MAHE , MADHAR NAGAR UDUPI
KARNATAKA
576104 |
|
|
Primary Sponsor
|
| Name |
KASTURBA HOSPITAL MANIPAL |
| Address |
KMC Manipal , MANIPAL UNIVERSITY
MAHE
Udupi
KARNATAKA
576104 |
| Type of Sponsor |
Private 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 |
| GAYATRI SUNEJA |
KASTURBA HOSPITAL MANIPAL |
MEDICINE DEPARTMENT
BALIGA BLOCK AND OPD BLOCK
KASTURBA HOSPITAL,MAHE
MADHAV NAGAR , MANIPAL
UDUPI
576104
Udupi
KARNATAKA |
9996438300
gayatrisuneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe-Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
controls |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ADULTS AGED 18-65 YEARS OF AGE DIAGNOSED WITH TYPE 2DM
PATIENTS ON A REGULAR TREATMENT REGIMEN FOR ATLEAST 3 MONTHS
(ADMITTED IN KASTURBA HOSPITAL, MANIPAL UNIVERSITY, MAHE. MADHA NAGAR, UDUPI
KARNATAKA
576104)
|
|
| ExclusionCriteria |
| Details |
INDIVIDUALS WITH TYPE 1 DIABETES
CUSHING SYNDROME OR ADRENAL DISORDER
PATIENTS WITH CHRONIC INFLAMMATORY DISEASE SUCH AS RHEUMATOID ARTHRITIS INFLAMMATORY
BOWEL DISEASE SLE
PATIENTS PRESENTING WITH SEPSIS UTI CELLULITIS
PATIENT WITH RECURRENT INFECTIONS
PREGNANT OR LACTATING WOMEN
PATIENTS ON OCPs
PATIENTS ON STEROIDS HORMONE REPLACEMENT THERAPY
PATIENTS ON INSULIN SECRETAGOUGES AND INSULIN PATIENTS ON ANTI THYROID DRUGS
PATIENTS ON ANTI-OBESITY DRUGS
(ADMITTED IN KASTURBA HOSPITAL, MANIPAL UNIVERSITY, MAHE. MADHA NAGAR, UDUPI
KARNATAKA
576104)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Strength and direction of correlation between serum leptin concentration and HOMA-IR at baseline in adults with Type 2 diabetes mellitus |
Baseline (single timepoint at enrolment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of serum leptin and insulin resistance across BMI groups |
baseline |
| Effect modification of BMI on leptin-insulin resistance relationship |
Baseline |
| Metabolic profile differences in Type2DM across BMI groups |
baseline |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
15/10/2025 |
| 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="1"
Months="6"
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 is a prospective cross-sectional observational study to be conducted at Kasturba Hospital Manipal from October 2025 to December 2026. The study aims to evaluate the correlation of serum leptin with insulin resistance in adults with type 2 diabetes mellitus (T2DM) across different BMI categories (normal, overweight, obese). A total of 98 participants aged eighteen to sixty five year old with Type 2 diabetics on stable treatment will be enrolled. Clinical anthropometric and biochemical parameters including fasting glucose, HbA1c ,lipid profile, fasting insulin and serum leptin with ELISA will be assessed. Insulin resistance will be calculated using HOMA IR. The primary outcome is to study the clinical and biochemical correlation of leptin with insulin resistance in Type 2 diabetes mellitus using anthropometric and biochemical parameters. Data will be analyzed using ANOVA/Kruskal Wallis correlation and regression method. Findings my help establish leptin as a biomarker of insulin resistance and guide personalized management of Type 2 diabetes mellitus. The study will be conducted after approval from ethics committee Date of first enrolment: 15/10/2015 Estimated trial duration: 14-15 months
|