Study to Assess the Efficacy of(IHRA)software in Early Detection of Chronic Diseases (Type 2 Diabetes, Hypertension and Dyslipidemia)

Not Applicable

Completed

• Registration Number: CTRI/2021/08/035507
• Lead Sponsor: Aarca Research India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-09-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1. Male and female participants aged � 25 years and � 65 years at the time of

consent

2. Participants at high risk of developing one of the following diseases:

- Type 2 diabetes

- Hypertension

- Dyslipidemia

3. Participants who can and are willing to provide Informed Consent.

4. Participants who understand and are willing to participate in the clinical study and

can comply with clinical trial protocol requirements.

Exclusion Criteria

1. Patients with established coronary artery disease as detected by

angiogram/TMT/ECG or patients with symptoms suggestive or ischemic heart

disease.

2. Patients with established Type 2 diabetes, hypertension and dyslipidemia.

3. Female patients with gestational diabetes.

4. Female patients who are pregnant at the time of screening

5. Patients with diagnosed thyroid dysfunction

6. Patients with Type 1 diabetes.

7. Patients with any other co-morbidities /medical illness

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. For type 2 Diabetes, OGTT blood test will be considered as the Gold Standard. <br/ ><br>2. Sensitivity and Specificity of IHRA in comparison with OGTT <br/ ><br>3. For Dyslipidemia, fasting LDL and Total Cholesterol blood tests will be considered as the Gold Standard. <br/ ><br>4. Sensitivity and Specificity of IHRA in comparison with fasting blood LDL levels <br/ ><br>and <br/ ><br>5. Sensitivity and Specificity of IHRA in comparison with fasting blood Total <br/ ><br>cholesterol levelsTimepoint: Few hours (2-3 hours)

Secondary Outcome Measures

Name	Time	Method
1. Correlation between IHRA score and OGTT, FPG, LDL, TC blood tests and MABP readingsTimepoint: few hours (2-3 hours)