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Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients With Fatty Liver

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ClinicalTrials.gov Identifier: NCT03646292
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on nonalcoholic fatty liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy n patients with type 2 diabetes and fatty liver will be compared and analyzed.

This study included a total of 60 patients (20 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.

The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in co-localized regions of interest within nine liver segments between three groups.


Condition or disease Intervention/treatment Phase
NAFLD - Nonalcoholic Fatty Liver Disease Type2 Diabetes Drug: Pioglitazone Drug: Empagliflozin Drug: Combination of pioglitazone and empagliflozin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will conduct to evaluate the efficacy of liver fat lowering and safety of empagliflozin 10mg, pioglitazone 15mg alone or in combination with empagliflozin 10mg/pioglitazone 15mg for 6 months.
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients With Fatty Liver
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Pioglitazone monotherapy
Pioglitazone 15mg 1T daily for 6 months
Drug: Pioglitazone
The investigators will compare the degree of liver fat between Pioglitazone monotherapy, Empagliflozin monotherapy, Combination of pioglitazone and empagliflozin following randomization.

Experimental: Empagliflozin monotherapy
Empagliflozin 10mg 1T daily for 6 months
Drug: Empagliflozin
The investigators will compare the degree of liver fat between Pioglitazone monotherapy, Empagliflozin monotherapy, Combination of pioglitazone and empagliflozin following randomization.

Experimental: Pioglitazone + Empagliflozin combination therapy
Pioglitazone 15mg + Empagliflozin 10mg combination 1T daily for 6 months
Drug: Combination of pioglitazone and empagliflozin
The investigators will compare the degree of liver fat between Pioglitazone monotherapy, Empagliflozin monotherapy, Combination of pioglitazone and empagliflozin following randomization.




Primary Outcome Measures :
  1. liver fat change measured by MRI-PDFF in co-localized regions of interest within each of nine liver segments [ Time Frame: 6 months ]
    MRI is used to measure the fat fraction in 9 liver segments, and this test has been reported to be more sensitive than the biopsy-based steatosis grade assessment in confirming liver fat changes in previous studies


Secondary Outcome Measures :
  1. Liver fibrosis measured by magnetic resonance elastography [ Time Frame: 6 months ]
    The secondary endpoint is to analyze the changes before and after drug administration for the following items: Liver fibrosis measured by magnetic resonance elastography

  2. The changes in lipid profile [ Time Frame: 6 months ]
    The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in lipid profile including LDL-C, TG, HDL, TC

  3. The changes in liver enzyme [ Time Frame: 6 months ]
    The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in liver enzyme including ALT, AST, GGT

  4. The changes in glucose metabolism [ Time Frame: 6 months ]
    The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in glucose metabolism including HOMAIR, fasting glucose, HbA1c, fasting insulin

  5. The changes in inflammation status [ Time Frame: 6 months ]
    The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in inflammation status including CRP, other biomarker



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged 19 years or over, under 75 years
  • A person diagnosed with nonalcoholic fatty liver in abdominal ultrasound (abdominal ultrasound can be substituted if there is a diagnosis of fatty liver through ultrasound within 1 year), or a person diagnosed with fatty liver in abdominal ultrasonography through screening because of clinical suspicion of fatty liver
  • Patients who are diagnosed with type 2 diabetes and who are treated with oral medication, excluding TZD or SGLT2i drug users within the last 12 weeks
  • Those who have voluntarily agreed in written form to participate in the clinical trial after hearing the explanation of this clinical trial
  • Those who understand the content of the clinical trial and are able to participate in the trial until the end of the clinical trial

Exclusion Criteria:

  • Diabetic patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes
  • Type 2 diabetic patients undergoing insulin therapy
  • Patients who have taken TZD or SGLT2i drugs within the last 12 weeks or have had a history of severe side effects after taking the above drugs
  • Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and those with a history of ketone phosphatemia (within 6 months)
  • Patients who meet the criteria for alcoholic liver disease (210 g / week for men in the last two years, 140 g / week for women)
  • People who take drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, etc.)
  • Allergic or hypersensitive to the drug or its constituents
  • Patients receiving oral or parenteral corticosteroid therapy chronic (within consecutive 14 days) within 8 weeks prior to screening require continual changes in corticosteroid dosage for therapeutic purposes
  • Patients with genetic problems such as galactosemia, Lapp lactase deficiency or glucose-galactose uptake
  • Malignant tumors that are currently undergoing treatment or progressive
  • Patients with a history of substance abuse or alcohol intoxication within 12 weeks
  • Human immunodeficiency virus (HIV)
  • Patients with severe infection, pre- and post-operative, and severe trauma
  • Patients with cardiac failure within 6 months (class III to IV in the NYHA classification)
  • Patients with acute cardiovascular disease within 12 weeks (patients with unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)
  • People with renal failure, chronic renal disease (estimated glomerular filtration rate <45 mL / min / 1.73 m2) or those who are difficult to use the medication due to dialysis
  • Pregnant or lactating women
  • A person who the examiner considers not eligible for clinical trials

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): NCT03646292


Locations
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Korea, Republic of
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Bong Soo Cha, MD    +82-2-2228-1932    bscha@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03646292     History of Changes
Other Study ID Numbers: 4-2018-0655
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Pioglitazone
Empagliflozin
2,4-thiazolidinedione
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action