Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Fatty liver disease is an increasingly recognized health problem in patients with type 2 diabetes mellitus (T2DM). Sodium glucose co-transporter type 2 (SGLT-2) inhibitors are a new class of anti-diabetic agents that cause weight loss by inducing glycosuria. The effect of SGLT-2 inhibitors on liver fat content is not evaluated. Empagliflozin is an orally active, selective inhibitor of SGLT-2. We hypothesized that Empagliflozin, when added to standard care for T2DM, would improve fatty liver disease. Therefore, the present study is planned to evaluate the effect of Empagliflozin on the liver fat content.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medanta, The Medicity, India
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Patients with T2DM of age 40 years and above

• Fatty liver disease (grade I or more on USG)

• Glycated A1C more than 7.0% but less than 10.0%

• Patient on standard care of T2DM (metformin, sulfonylureas, DPP-4 inhibitors or insulin, in any combination).

Exclusion Criteria:

1. Serum creatinine more than 1.5 mg/dL

2. Pregnancy

3. Participants treated with pioglitazone or vitamin E in the immediate past 6 months

4. Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).