| CTRI Number |
CTRI/2019/08/020792 [Registered on: 20/08/2019] Trial Registered Prospectively |
| Last Modified On: |
19/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of cardivascular risk in type 2 diabetes mellitus |
|
Scientific Title of Study
|
A cross sectional study to evaluate the cardiovascular risk score 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 Arshiya |
| Designation |
Junior resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09646732003 |
| Fax |
|
| Email |
arshiyasehgal26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Professor & HOD |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala
Patiala
PUNJAB
147001
India |
| Phone |
09646732001 |
| Fax |
|
| Email |
vijayksehgal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshiya |
| Designation |
Junior resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala
PUNJAB
147001
India |
| Phone |
09646732003 |
| Fax |
|
| Email |
arshiyasehgal26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Patiala |
|
|
Primary Sponsor
|
| Name |
Dr Arshiya |
| Address |
Government Medical College, Patiala |
| 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 Arshiya |
Government Medical College & Rajindra Hospital |
Room No 14, Department of Medicine
Patiala
PUNJAB |
09646732003
arshiyasehgal26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionn ethics comitte |
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, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age > 40 years
Sex- Both male and female
Patients with FBS > 110 mg/dl and HB1ac >8%
|
|
| ExclusionCriteria |
| Details |
Children
Pregnant women
Seriously ill and acutely ill patients
Patients who are not willing to give written informed consent
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the cardiovascular risk score in subjects with type 2 diabetes mellitus |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare UKPDS and WHO/ISH charts |
4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/08/2019 |
| 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="0"
Months="4"
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)?
|
|
Brief Summary
|
INTRODUCTION- Cardiovascular
disease is the leading cause of mortality worldwide, including in low and
middle income countries. It is well known that diabetes is associated with
increased cardiovascular morbidity and mortality. Risk factors of type2 diabetes mellitus includes
unmodifiable risk factors like age, sex, ethnic status and family history and
modifiable risk factors like weight, smoking, alcohol, hypertension, sedentary
lifestyle, hyperlipidaemia and hypercholesterolemia .Estimates of CVD risk can
be useful for both clinicians and patients AIMS & OBJECTIVES- To evaluate the
cardiovascular risk score in subjects with
type 2 diabetes mellitus MATERIALS & METHODS - A cross-sectional observational
study will be carried
in diabetic patients attending Medicine
OPD /Ward in Government
Medical College, Patiala.
Informed consent will
be obtained and
the patients will
be interviewed followed
by detail examination.After fulfilment of inclusion and exclusion
criteria, 10 year Cardiovascular risk assessment will be done using UKPDS risk
engine. CLINICAL SIGNIFICANCE- Estimates
of CVD risk can be useful for both clinicians and patients: for clinicians, it
is a prognostic information that can support them in the choice of therapeutic
and preventive strategies; and for patients, it can be a motivation tool to
adopt healthy lifestyle measures and to observe prescribed risk-modifying
treatments
|