Cardiac Magnetic Resonance (MR) changes with empagliflozin treatment in people with type 2 diabetes: a pilot study

Phase 4

Completed

• Conditions: type 2 diabetes; heart failure; cardiovascular disease; Metabolic and Endocrine - Diabetes; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616001535460
• Lead Sponsor: Baker IDI Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-08
• Study Completion: 2017-10-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Sex: all

Age: 18 - 75 years

Disease status and severity: type 2 diabetes with HbA1c > 7% (in accordance with PBS requirements)

Informed consent: participant must be able to give personal informed consent
Participation in the study: participant must be able to co-operate sufficiently to allow the proposed study to progress.

Concomitant medications: no restriction is made in the use of concomitant medications, which will be left to the treating specialist

Exclusion Criteria

Age: less than 18 years and greater than 75 years

Disease status and severity: type 1 diabetes and type 2 diabetes with HbA1c less than 7%

Pregnancy and breast feeding: females must not be pregnant or breast feeding or at risk of becoming pregnant (permanent or effective contraception required – hysterectomy, tubal ligation, IUD or OCP)

Concomitant medications: No restriction in concomitant medications except the use of an SGLT2 inhibitor the control group.

Contraindications to magnetic resonance imaging: metallic implants

Study & Design

• Study Type: Interventional
• Study Design: Not specified