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Clinical Trials/CTRI/2023/11/059500
CTRI/2023/11/059500Not yet recruitingPhase 1

Echocardiographic study of Left Ventricular diastolic dysfunction in Type 2 Diabetes Mellitus patients and correlation with hba1c levels.

Kodukula Naga Venkat Bharath1 site in 1 country100 target enrollmentStarted: November 11, 2023Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Diabetes mellitus type 2 is associated with left ventricular diastolic dysfunction.

Study Overview

Brief Summary

This study aims to find out the incidence of Left ventricular diastolic dysfunction in patients with Diabetes mellitus type 2. Patients can be newly diagnosed or have a history of DMt2. At presentation all the participants will be tested with serum HbA1c levels which gives us an idea of blood sugar control for the past 3 months. Then the patient will go on to have a 2d echocardiography done, where in parameters for diastolic dysfunction will be measured.  Presence or absence of Diastolic dysfunction will be determined by recommendations made by American society of Echocardiography and European Association of cardiovascular Imaging in 2016. The diastolic dysfunction if present will be graded as mild , moderate or Severe and compared to the earlier HbA1c levels.  There will be another comparison of severity of diastolic dysfunction between smoking and non smoking Diabetic patients.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
50.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with DM type 2 .Cases were selected as per the diagnostic criteria laid down by the American Diabetes Association.
  • Fasting blood glucose (FBS) of 126 mg/dl or higher or a 2-hr postprandial blood glucose (PPBS) level of 200 mg/dl or higher during a 75-gm oral glucose tolerance test or random plasma glucose of 200 mg/dl or higher in a patient with symptoms of hyperglycemia or HbA1c 6.5% or higher.

Exclusion Criteria

  • Patients with systemic hypertension, coronary artery disease, ischemic heart disease, cardiomyopathy, valvular disorders, connective tissue disorder, CLD, CKD and thyroid dysfunction.

Outcomes

Primary Outcomes

Diabetes mellitus type 2 is associated with left ventricular diastolic dysfunction.

Time Frame: Baseline

Secondary Outcomes

  • Smoking worsens diastolic dysfunction in diabetic patients(Baseline)

Investigators

Sponsor
Kodukula Naga Venkat Bharath
Sponsor Class
Other [self]

Study Sites (1)

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