Health Trials

A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants

ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorNovo Nordisk A/S

About this trial

The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged greater than equal to (≥) 40 and less than (<) 70 years

Male or female

Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023

Disqualifiers

If any exclusion criterion is met, the participant will be excluded from the study.

T1DM or gestational diabetes

Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM

Pregnant women

Trial population

Participants with T2DM identified in south asian countries.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No treatment given

    Other intervention

    No treatment given

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: T2DM Cohort1 intervention

Trial outcomes

Primary outcomes

1

Cardiometabolic profile: Systolic blood pressure at baseline

Millimetres of mercury (mmHg).

Time frame
At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
2

Cardiometabolic profile: Waist circumference at baseline

Measured in centimetre (cm).

Time frame
At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
3

Cardiometabolic profile: Hip circumference at baseline

Measured in cm.

Time frame
At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
4

Cardiometabolic profile: Height at baseline

Measured in cm.

Time frame
At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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