| CTRI Number |
CTRI/2021/05/033702 [Registered on: 20/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find the Association of Cardiovascular risk estimate with degree of Atherosclerosis in patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Association of Cardiovascular risk estimate with degree of Atherosclerosis in patients with 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 Pamarthi Meghavarna |
| Designation |
Junior Resident, MD ,General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8919176795 |
| Fax |
|
| Email |
meghavarnap0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivashankar KN |
| Designation |
Professor and Guide |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pamarthi Meghavarna |
| Designation |
Junior Resident, MD, General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,Kasturba Medical College,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8919176795 |
| Fax |
|
| Email |
meghavarnap0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Karnataka , 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Pamarthi Meghavarna |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal |
| 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 Pamarthi Meghavarna |
Kasturba Hospital, KMC, Manipal |
Department of General Medicine male and female medical wards and medicine opd
Department of Radiodiagnosis,Room NO: 10, Ultrasound room
Udupi
KARNATAKA |
8919176795
meghavarnap0@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
41.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Type 2 Diabetes Mellitus with age above 40 years in whom CIMT is done as standard of care by the Department of Radiology will be included in the study. |
|
| ExclusionCriteria |
| Details |
Ischemic heart disease on treatment, Acute coronary syndrome, Post Percutaneous Transluminal Coronary Angioplasty, Post Coronary Artery Bypass Grafting, Dyslipedemia on treatment, CVA, Peripheral Vascular Disease, CKD and Connective tissue disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the 10 years risk of development of cardiovascular disease in diabetic patients using different risk engines. |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate between 10 years cardiovascular risk using different risk engines with Carotid Intima Media Thickness, so that morbidity and mortality due to diabetes in long term can be reduced. |
2 years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/05/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a hospital based , cross- sectional, observational study done in type 2 diabetes Mellitus patients, to estimate 10 years cardiovascular risk by using different risk engines UKPDS,FRS,Q RISK and ASCVD. To measure the Carotid Intima Media Thickness by ultrasonography in diabetic patients and to correlate between 10 years cardiovascular risk using different risk engines with CIMT, so that morbidity and mortality due to diabetes in long term can be reduced. |