| CTRI Number |
CTRI/2020/12/030025 [Registered on: 24/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of simple blood test to predict diabetic complications |
|
Scientific Title of Study
|
The role of platelet indices in predicting the micro-vascular complications in type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwani Kumar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, 2nd Floor, New OPD Block, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8217419977 |
| Fax |
|
| Email |
ashwani122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Rao |
| Designation |
Associate Professor, General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, 2nd Floor, New OPD Block, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9901731924 |
| Fax |
|
| Email |
ragsmanipal1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwani Kumar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, 2nd Floor, New OPD Block, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8217419977 |
| Fax |
|
| Email |
ashwani122@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College, Manipal, Udupi, 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 |
| Dr Ashwani Kumar |
Kasturba Medical College, Manipal |
Department of General Medicine, 2nd Floor, New OPD block, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA |
08217419977
ashwani122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Diabetic Individuals |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (3) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, (4) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals above 18 years of age, diagnosed as having T2DM, according to American Diabetic Association (ADA) Criteria, with or without micro-vascular complications |
|
| ExclusionCriteria |
| Details |
Anaemia, according to WHO cut off levels, malignancies, myeloproliferatve disorders, ongoing infections, on Drugs like anti-platelets and those known to cause bone marrow suppression, thrombocytopenia, Pregnancy, hypothyroidism, recent blood transfusion (< 2 weeks), smokers, T2DM with macro-vascular complications, T2DM with severe illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A positive correlation of increased platelet indices with micro-vascular complications in type 2 diabetes mellitus |
Correlation will be observed at the time of enrolment into the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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)
|
26/12/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Purpose - To investigate the efficacy of Platelet Indices in predicting Micro-vascular complications of DM
Study Hypothesis - Diabetes Mellitus and its complications are major contributors in morbidity and economic burden. Correlating simple, economical, readily available parameters to risk of developing micro-vascular complications, will help alleviate the situation. A study done by Walinjkar RS, Khadse S, Kumar S et al in Maharashtra suggested that Platelet indices, namely MPV, PCT, PDW, and P/LCR were significantly higher in diabetic individuals than those in age and gendermatched controls. Moreover, the increase in MPV, PDW, and P/LCR was more significant in diabetic subjects with micro-vascular complications when compared with those without micro-vascular complications. Platelet dysfunction also showed a positive association with HbA1C, retinopathy, nephropathy, and neuropathy individually. |