Effect of Dapagliflozin on Unconscious functions of the heart in Diabetic Patients.

An Open Label Randomized Controlled Trial to evaluate the effect of Dapagliflozin on Cardiac autonomic functions in T2DM patients - Nill

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065339

Enrollment

Registered

2024-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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: Tab Dapagliflozin: Dapagliflozin 10 mg once a day for 6 months Standard of care (Vildagliptin 50 mg twice a day Metformin 500 mg twice a day) for 6 months Control Intervention1: standar

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 DM patients 2. Patients who are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Type 1 DM 2. Hypertensives 3. heart failure 4. valvular disease 5. COPD 6. Renal failure • Patients on drugs like beta-receptor blockers, antihypertensives, sedatives

Design outcomes

Primary

Measure	Time frame
The study will evaluate whether taking dapagliflozin will reduce the risk of cardiac autonomic dysfunction compared to a control group among patients with type 2 diabetes mellitus (T2DM).Timepoint: 6 Months	—

Secondary

Measure	Time frame
The study will evaluate the effect of SGLT2 inhibitors on BMI, lipid profile in patients of T2DM.Timepoint: 6 Months	—

Countries

India

Contacts

Public ContactKrishna Keerthi Annepu

Jawaharlal Nehru Medical College, AMU

afaraz83@gmail.com9997625257

Outcome results

None listed

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