CAPTIVATE India - A Study to Assess the Prevalence of Cardiovascular Disease (CVD) in Individuals With Type 2 Diabetes Mellitus (T2DM) in India

NCT ID: NCT07121114

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-09

Study Completion Date

2025-07-09

Brief Summary

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This is a cross-sectional study assessing the prevalence of Cardiovascular Disease and describing cardio-renal risk factors among individuals with Type 2 Diabetes Mellitus in India based on medical records.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort 1

The population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM).

No treatment given

Intervention Type OTHER

No treatment given

Interventions

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No treatment given

No treatment given

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female individuals with type 2 diabetes mellitus (T2DM), aged above or equal to 18 years.
* A confirmed diagnosis of T2DM before ethical clearance at every participating institution.
* 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.

Exclusion Criteria

* Diagnosis of Type 1 diabetes, or maturity-onset diabetes of the young (MODY).
* Known congenital heart disease or malformation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834), Study Director

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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U1111-1310-3556

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-8323

Identifier Type: -

Identifier Source: org_study_id

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