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

Effect of Sodium-glucose Co-Transporter 2 (SGLT2) inhibitors of Left Ventricular Mass and Diastolic Function in Type-2 Diabetes Mellitus Patients at a Tertiary Care Hospital in South India.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023195
Enrollment
70
Registered
2020-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Dapagliflozin /Empagliflozin: Tablet Dapagliflozin 10mg/ empagliflozin 10, 25 mg under the background therapy ofTablet Metformin (1500-2500mg) Control Intervention1: Glimiperide: Tablet

Sponsors

Nizams Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients aged between 18 and 65 years of either sex. 2) Type 2 Diabetes Mellitus Patients with HbA1c >=7% 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

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.

Design outcomes

Primary

MeasureTime frame
Primary outcome 1. Change in LV mass and diastolic function parameters (E/eratio, IVRT, DT) Timepoint: 0, 12, 24 weeks—

Secondary

MeasureTime frame
Secondary outcome 1. Change in Neck Circumference, Waist Circumference, Hip Circumference, W/H ratio. 2. Change in HbA1c, FBS, PPBS. Timepoint: 0, 4, 12, 24 weeks—

Countries

India

Contacts

Public ContactRuby Raphael

Nizams Institute of Medical Sciences

adonepudi@yahoo.co.in9848923036

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026