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Trial record 34 of 343 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes (E-LIFT)

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ClinicalTrials.gov Identifier: NCT02686476
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Mohammad Shafi Kuchay, Medanta, The Medicity, India

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.

Condition or disease Intervention/treatment Phase
Non Alcoholic Fatty Liver Disease Drug: Empagliflozin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes: A 12-week Randomized Clinical Study
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: Empagliflozin dose group
Patient Receive Standard of Care with Empagliflozen
Drug: Empagliflozin
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
Other Name: Jardiance

No Intervention: Standard dose group
Standard care for Type 2 Diabetes Mellitus upgraded without Empagliflozin



Primary Outcome Measures :
  1. Change in Liver Fat [ Time Frame: 3 Months ]
    To evaluate the change in liver fat content at baseline and 3 Months


Secondary Outcome Measures :
  1. Pancreatic fat content [ Time Frame: 3 Months ]
    To evaluate the changes in pancreatic fat content at baseline and 3 Months

  2. visceral fat [ Time Frame: 3 Months ]
    To evaluate the changes in visceral fat content at baseline and 3 Months

  3. subcutaneous fat [ Time Frame: 3 Months ]
    To evaluate the changes in subcutaneous fat content at baseline and 3 Months



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686476


Locations
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India
Division Of Endocrinology , Medanta The Medicity Sec 38
Gurgaon, Haryana, India, 122001
Sponsors and Collaborators
Medanta, The Medicity, India
Investigators
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Principal Investigator: Mohammad S Kuchay, MD,DM Endocrinologist

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Mohammad Shafi Kuchay, Endocrinologist, Medanta, The Medicity, India
ClinicalTrials.gov Identifier: NCT02686476     History of Changes
Other Study ID Numbers: MMELIFT01
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr Mohammad Shafi Kuchay, Medanta, The Medicity, India:
Empagliflozin, Fatty Liver Disease

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs