| CTRI Number |
CTRI/2023/12/060795 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of NT-ProBNP marker to predict the cardiovascular risk in individuals with type 2 diabetes. |
|
Scientific Title of Study
|
NT-ProBNP: a novel predictor of cardiovascular risk in type 2 diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahana Shetty |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Endocrinology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9944745014 |
| Fax |
|
| Email |
sahana.shetty@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sahana Shetty |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Endocrinology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9944745014 |
| Fax |
|
| Email |
sahana.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sahana Shetty |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Endocrinology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9944745014 |
| Fax |
|
| Email |
sahana.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Roche Diagnostics India Pvt. Ltd. Silver Utopia, Cardinal Gracious Rd, Chakala, Andheri East, Mumbai, Maharashtra 400069 |
|
|
Primary Sponsor
|
| Name |
Roche Diagnostics |
| Address |
Mumbai, Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sahana Shetty |
Kasturba Hospital |
Room No. 1, Department of Endocrinology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9944745014
sahana.shetty@manipal.edu |
|
|
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 |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus patients with or without cardiovascular disease of either gender. |
|
| ExclusionCriteria |
| Details |
Subjects who had cancer and renal dysfunction, Pregnancy, Subjects with valvular, rheumatic, and congenital heart disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NT-ProBNP, fasting glucose, HbA1c, HDL, triglycerides, total cholesterol, LDL, micro-albuminuria, and creatinine |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk stratification assessment for CVD using risk tools |
baseline |
|
|
Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
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)
|
01/01/2024 |
| 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
|
NT-proBNP (N-terminal pro-B-type natriuretic peptide) is a biomarker that has significant medical value in the assessment and management of cardiovascular diseases. The measurement of NT-proBNP levels in the blood provides valuable information for the risk, diagnosis, prognosis, and monitoring of various cardiovascular conditions. NT-proBNP levels have been found to provide valuable prognostic information in patients with acute coronary syndrome (ACS) and a risk predictor marker for CVD in type 2 diabetes patients. Elevated levels of NT-proBNP in CVD patients are associated with an increased risk of adverse cardiovascular events, including mortality. The measurement of NT-proBNP can help risk-stratify patients with heart failure and guide for superlative treatment decisions. The study aims to determine the NT-Pro BNP levels in type 2 diabetes patients with and without CVD in comparison to healthy controls in order to assess the risk of marker in CVD. The study also assess the differences between the three groups by evaluating the risk stratification of CVD in each group using a standard CVD risk tool. The outcome measures include the levels of NT-proBNP to find the risk of CVD. Also, the NT-ProBNP levels will be correlated with other markers such as fasting glucose, HbA1c, HDL, triglycerides, total cholesterol, LDL, micro-albuminuria, and creatinine to find their association. Risk stratification assessment for CVD using risk tools is also included in order to compare the risk analysis between the groups. Elevated levels of NT-proBNP in type 2 diabetes are associated with an increased risk of cardiovascular disease. The measurement of NT-proBNP can help risk-stratify patients with heart failure and guide for superlative treatment decisions.
|