The following criteria are necessary for subjects to be eligible for this study:
1.Male of female individuals with T2DM, greater than or equal to 18 years of age
2. A confirmed diagnosis of T2DM, and the availability of data before ethical clearance at every participating institution
3. Medical records available between 01 January 2024 to 30 September 2024 ought to have the
data points required for the primary and secondary objectives. Medical records must have at
least 6 months (greater than or equal to 180 days) of follow-up data from the date of diagnosis
ExclusionCriteria
Details
Subjects who meet any of the following criteria will be disqualified from entering the study:
1.Diagnosis of Type 1 diabetes, or maturity-onset diabetes of the young (MODY)
2.Known congenital heart disease or malformation
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of individuals with established CVD i.e. who have been diagnosed with either cerebrovascular disease, coronary heart disease (CHD), heart failure, cardiac arrhythmia or conduction abnormalities, aortic disease, peripheral artery disease (PAD), or carotid artery disease
At least 180 days (6 months) from the date of diagnosis
Secondary Outcome
Outcome
TimePoints
· Proportion of individuals with renal disease & cardio-renal risk factors.
· Characterize individuals based on demographics, clinical parameters & treatment patterns
At least 180 days (6 months) from the date of diagnosis
Target Sample Size
Total Sample Size="6500" Sample Size from India="6500" 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)
14/04/2025
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="3" Months="7" 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 is a multi-center, non-interventional, cross-sectional study assessing the prevalence of CVD and describing cardio-renal risk factors among individuals with T2DM in India. By estimating the prevalence of CVD and exploring associated cardio-renal risk factors, the study seeks to provide valuable insights that will help contextualize the disease burden and unmet needs. Additionally, the study strives to provide the most recent evidence on CVD prevalence in Indian individuals with T2DM, focusing on baseline demographic and clinical characterization.