Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes
E-LIFT
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 15, 2019
August 1, 2019
1.5 years
February 10, 2016
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Liver Fat
To evaluate the change in liver fat content at baseline and 3 Months
3 Months
Secondary Outcomes (3)
Pancreatic fat content
3 Months
visceral fat
3 Months
subcutaneous fat
3 Months
Study Arms (2)
Empagliflozin dose group
ACTIVE COMPARATORPatient Receive Standard of Care with Empagliflozen
Standard dose group
NO INTERVENTIONStandard care for Type 2 Diabetes Mellitus upgraded without Empagliflozin
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Serum creatinine more than 1.5 mg/dL
- Pregnancy
- Participants treated with pioglitazone or vitamin E in the immediate past 6 months
- Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division Of Endocrinology , Medanta The Medicity Sec 38
Gurgaon, Haryana, 122001, India
Related Publications (7)
Reeder SB, Cruite I, Hamilton G, Sirlin CB. Quantitative Assessment of Liver Fat with Magnetic Resonance Imaging and Spectroscopy. J Magn Reson Imaging. 2011 Oct;34(4):729-749. doi: 10.1002/jmri.22775. Epub 2011 Sep 16.
PMID: 22025886BACKGROUNDFerrannini E, Seman L, Seewaldt-Becker E, Hantel S, Pinnetti S, Woerle HJ. A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):721-8. doi: 10.1111/dom.12081. Epub 2013 Mar 4.
PMID: 23398530RESULTRosenstock J, Seman LJ, Jelaska A, Hantel S, Pinnetti S, Hach T, Woerle HJ. Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes Obes Metab. 2013 Dec;15(12):1154-60. doi: 10.1111/dom.12185. Epub 2013 Aug 22.
PMID: 23906374RESULTReeder SB, Sirlin CB. Quantification of liver fat with magnetic resonance imaging. Magn Reson Imaging Clin N Am. 2010 Aug;18(3):337-57, ix. doi: 10.1016/j.mric.2010.08.013.
PMID: 21094444RESULTLe TA, Chen J, Changchien C, Peterson MR, Kono Y, Patton H, Cohen BL, Brenner D, Sirlin C, Loomba R; San Diego Integrated NAFLD Research Consortium (SINC). Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: a randomized controlled trial. Hepatology. 2012 Sep;56(3):922-32. doi: 10.1002/hep.25731. Epub 2012 Jul 2.
PMID: 22431131RESULTKrishan S, Jain D, Bathina Y, Kale A, Saraf N, Saigal S, Choudhary N, Baijal SS, Soin A. Non-invasive quantification of hepatic steatosis in living, related liver donors using dual-echo Dixon imaging and single-voxel proton spectroscopy. Clin Radiol. 2016 Jan;71(1):58-63. doi: 10.1016/j.crad.2015.10.002. Epub 2015 Nov 7.
PMID: 26555703RESULTKuchay MS, Krishan S, Mishra SK, Farooqui KJ, Singh MK, Wasir JS, Bansal B, Kaur P, Jevalikar G, Gill HK, Choudhary NS, Mithal A. Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial (E-LIFT Trial). Diabetes Care. 2018 Aug;41(8):1801-1808. doi: 10.2337/dc18-0165. Epub 2018 Jun 12.
PMID: 29895557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad S Kuchay, MD,DM
Endocrinologist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Endocrinologist
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 19, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
August 15, 2019
Record last verified: 2019-08