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

Conditions

• Non Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  group I (n = 50): T2DM patients receiving standard care for T2DM (metformin, sulfonylurea, DPP-4 inhibitor or insulin, in any combination) plus 10 mg of Empagliflozin per day

Study Details

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.

Key Dates

Start date

Mar 31, 2016

Status verified

Aug 2019

Primary completion

Sep 30, 2017

Completion

Dec 31, 2017

Study Design

Enrollment

100 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Empagliflozin dose group
  Patient Receive Standard of Care with Empagliflozen
• No Intervention: Standard dose group
  Standard care for Type 2 Diabetes Mellitus upgraded without Empagliflozin

Primary Outcome Measure

Change in Liver Fat [ Time Frame: 3 Months ]