| CTRI Number |
CTRI/2025/04/085507 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Platelet to albumin ratio to predict diabetic nephropathy among T2DM |
|
Scientific Title of Study
|
The platelet to albumin ratio a predictive marker in assessment of diabetic nephropathy among 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 |
Komal Dhamanekar |
| Designation |
Student |
| Affiliation |
KLEs Jawaharlal Nehru Medical College Belagavi |
| Address |
Department of Biochemistry,
KLEs JNMC,
Nehru nagar,
Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7337852391 |
| Fax |
|
| Email |
kdhamanekar44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Channashetti |
| Designation |
Assitant Professor |
| Affiliation |
KLEs Jawaharlal Nehru Medical College Belagavi |
| Address |
Department of Biochemistry,
KLEs JNMC,
Nehru nagar,
Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9538635336 |
| Fax |
|
| Email |
dcrashmi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reshma Channashetti |
| Designation |
Assitant Professor |
| Affiliation |
KLEs Jawaharlal Nehru Medical College Belagavi |
| Address |
Department of Biochemistry,
KLEs JNMC,
Nehru nagar,
Belagavi-590010
KARNATAKA
590010
India |
| Phone |
9538635336 |
| Fax |
|
| Email |
dcrashmi@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Komal Dhamanekar |
| Address |
Department of Biochemistry,
KLEs JNMC,
Nehru nagar,
Belagavi-590010 |
| 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 Reshma Channashetti |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Center |
Department of Nephrology, OPD no. 28, Second floor
Belgaum
KARNATAKA |
9538635936
dc.rashmi@yahoo.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 |
| Healthy Human Volunteers |
Non Diabetic Patients |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Case: Patients with T2DM
Control: Non diabetic patients |
|
| ExclusionCriteria |
| Details |
Acute or chronic infections
Auto immune diseases
Tumors
Heamatological Diseases
Liver insufficiency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of Platelet to Albumin ratio in Diabetic Nephropathy among T2DM |
24 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
06/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Diabetic
nephropathy is a leading cause of chronic kidney diseases and Endstage
renal failure, affecting approximately 40% of patients with T2DM.Early
detection of diabetic nephropathy plays crucial role in mitigating disease
progression ,This study aims to contribute to development of more effective
diagnostic and predictive marker for diabetic nephropathy in T2DM patients |