| CTRI Number |
CTRI/2022/03/040899 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chances of developing heart disease in diabetes patients |
|
Scientific Title of Study
|
Prospective study to assess the cardiovascular risk in patients of 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 Nikhil Ashok Gharat |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil Hospital |
| Address |
Department of Medicine, School of Medicine, Dr.D.Y.Patil Hospital and deemed to be University,Sector 5 Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9767770799 |
| Fax |
|
| Email |
ngharat10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil Ashok Gharat |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil Hospital |
| Address |
Department of Medicine, School of Medicine, Dr.D.Y.Patil Hospital and deemed to be University,Sector 5 Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9767770799 |
| Fax |
|
| Email |
ngharat10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivedita Moulick |
| Designation |
Head of Department and Professor |
| Affiliation |
Dr.D.Y.Patil Hospital |
| Address |
Department of Medicine, School of Medicine, Dr.D.Y.Patil Hospital and deemed to be University,Sector 5 Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9833022282 |
| Fax |
|
| Email |
ndmoulick@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| School of Medicine,D.Y.Patil deemed to be university, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil Ashok Gharat |
| Address |
Department of Medicine, School of Medicine, Dr.D.Y.Patil Hospital and deemed to be University,Sector 5 Nerul, Navi Mumbai |
| 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 Nikhil Ashok Gharat |
Dr.D.Y.Patil Hospital and deemed to be University |
Department of Medicine, School of Medicine, Dr.D.Y.Patil Hospital and deemed to be University,Sector 5 Nerul, Navi Mumbai
Thane
MAHARASHTRA |
09767770799
ngharat10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ADULT MALES OR FEMALES WITH A DIAGNOSIS OF TYPE 2 DIABETES MELLITUS |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH KNOWN CARDIOVASCULAR DISEASE
2.IMMUNOCOMPROMISED PATIENTS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the cardiovascular events risk in patients of type 2 diabetes mellitus using PROCAM scoring method |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the burden of Cardiovascular risk factors in patients of type 2 diabetes mellitus |
1 year |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2022 |
| 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
|
The present study is a prospective, cross sectional study for completion under Dr.D.Y.Patil Hospital and deemed to be university Total Duration of trial is 1 year Title : Prospective study to assess the cardiovascular risk in patients of type 2 diabetes mellitus
Aim : To calculate the cardiovascular events risk in patients of type 2 diabetes mellitus using PROCAM scoring method
Study Group : Sample size 200
Study Centre: School of medicine,Dr.D.Y.Patil Hospital and deemed to be university,Nerul,Navi Mumbai
PG Scholar : Dr Nikhil Ashok Gharat
Guide : Dr Nivedita Moulick |