Non Alcoholic Fatty Liver Disease Clinical Trial
— E-LIFTOfficial title:
Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes: A 12-week Randomized Clinical Study
NCT number | NCT02686476 |
Other study ID # | MMELIFT01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 2017 |
Verified date | August 2019 |
Source | Medanta, The Medicity, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
India | Division Of Endocrinology , Medanta The Medicity Sec 38 | Gurgaon | Haryana |
Lead Sponsor | Collaborator |
---|---|
Medanta, The Medicity, India |
India,
Ferrannini 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 — View Citation
Krishan 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 — View Citation
Le 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 — View Citation
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.22580. Epub 2011 Sep 16. Review. — View Citation
Reeder 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. Review. — View Citation
Rosenstock 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Liver Fat | To evaluate the change in liver fat content at baseline and 3 Months | 3 Months | |
Secondary | Pancreatic fat content | To evaluate the changes in pancreatic fat content at baseline and 3 Months | 3 Months | |
Secondary | visceral fat | To evaluate the changes in visceral fat content at baseline and 3 Months | 3 Months | |
Secondary | subcutaneous fat | To evaluate the changes in subcutaneous fat content at baseline and 3 Months | 3 Months |
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