Effect of SGLT2 inhibitors on heart function in type 2 diabetic patients in south India

Phase 4

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2020/02/023195
• Lead Sponsor: izams Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Patients aged between 18 and 65 years of either sex.

2)Type 2 Diabetes Mellitus Patients with HbA1c >=7% <= 10%.

3. patients asymptomatic and without history of CVD.

4)Patients on stable dose of tablet metformin (1000-2500mg) plus any 2 of the folloowing durg combinations- tablet glimiperide (2-8mg), tablet gliclazide SR 30-80 mg, tablet linagliptin 5mg, tablet sitaglyptin 100mg, tablet vildagliptin 50mg, tablet tenaligliptin 20mg since last 3 months.

5)Patients who are SGLT2 inhibitor naïve.

Exclusion Criteria

1)Patients on insulin and GLP-1 analogues

2)Patients with h/o type 1 Diabetes Mellitus, Congestive Cardiac Failure, Myocardial Infarction, Renal & Hepatic impairment.

3)Pregnant women and lactating mothers

4)Patients not willing to give informed consent and comply with study related procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome <br/ ><br> <br/ ><br>1.Change in LV mass and diastolic function parameters (E/eratio, IVRT, DT) <br/ ><br>Timepoint: 0, 12, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcome <br/ ><br>1.Change in Neck Circumference, Waist Circumference, Hip Circumference, W/H ratio. <br/ ><br>2.Change in HbA1c, FBS, PPBS. <br/ ><br>Timepoint: 0, 4, 12, 24 weeks