| CTRI Number |
CTRI/2024/08/072661 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate cardiac dysfunction in patients of diabetes mellitus using certain markers |
|
Scientific Title of Study
|
A Study on Association between NT-ProBNP levels and Myocardial Dysfunction in Patients of 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 |
Dr Rajam Iyer Bhavana |
| Designation |
PG Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Medicine, Maulana Azad Medical College
New Delhi
Delhi
110002
India
Central
DELHI
110002
India |
| Phone |
8800303247 |
| Fax |
|
| Email |
rajamiyer.bhavana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja Block, Department of Medicine, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9910555433 |
| Fax |
|
| Email |
pradeepkumar.pacific@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL Taneja Block, Department of Medicine, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9910555433 |
| Fax |
|
| Email |
pradeepkumar.pacific@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government 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 Rajam Iyer Bhavana |
Lok Nayak Hospital |
Room No. 324, Medicine OPD, Department of Medicine, Lok Nayak Hospital
New Delhi
Delhi
110002
India
Central
DELHI |
8800303247
rajamiyer.bhavana@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: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years of age with Type 2 Diabetes Mellitus |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of hypertension, significant valvular heart disease, congenital heart disease, persistent arrhythmias, and ischemic heart disease and thyroid disease.
2. The chronic intake of any drug that is known to cause cardiac disease, in the previous 6 months before inclusion (that would include chronic alcoholism, anti-cancer drugs).
3. Patients with hypertrophic cardiomyopathy and hypertrophic obstructive cardiomyopathy.
4. Patients with morbid obesity, renal failure and other major organ failure.
5. Patients in fluid overload state like in Pregnancy, Severe Anemia ( Hemoglobin less than 7gm/dl).
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association between the NT-ProBNP levels and myocardial dysfunction in patients of type 2 diabetes mellitus |
Patients aged more than 18 years presenting to OPD with Type 2 Diabetes Mellitus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the myocardial dysfunction in patients of Type 2 Diabetes Mellitus |
At baseline, at 2 weeks |
|
|
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)
|
30/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims at the assessment of LV function with non-invasive techniques in type 2 diabetics using echocardiography for detecting structural and functional cardiac abnormalities which are then correlated with levels of brain natriuretic peptide (BNP) for early planning of management before passing into overt heart failure. |