Empagliflozin Effectively Lowers Liver Fat Content in Well-Controlled Type 2 Diabetes: A Randomized, Double-Blind, Phase 4, Placebo-Controlled Trial
To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D). Patients with T2D ( = 84) (HbA 6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were ran...
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| Published in: | Diabetes care Vol. 43; no. 2; p. 298 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
01.02.2020
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| ISSN: | 1935-5548, 1935-5548 |
| Online Access: | Get more information |
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| Abstract | To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).
Patients with T2D (
= 84) (HbA
6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were randomly assigned to 24 weeks of treatment with 25 mg daily EMPA or placebo. The primary end point was the difference of the change in LFC as measured with magnetic resonance methods from 0 (baseline) to 24 weeks between groups. Tissue-specific insulin sensitivity (secondary outcome) was assessed by two-step clamps using an isotope dilution technique. Exploratory analysis comprised circulating surrogate markers of insulin sensitivity and liver function. Statistical comparison was done by ANCOVA adjusted for respective baseline values, age, sex, and BMI.
EMPA treatment resulted in a placebo-corrected absolute change of -1.8% (95% CI -3.4, -0.2;
= 0.02) and relative change in LFC of -22% (-36, -7;
= 0.009) from baseline to end of treatment, corresponding to a 2.3-fold greater reduction. Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4];
< 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed. EMPA treatment also led to placebo-corrected changes in uric acid (-74 mol/L [-108, -42];
< 0.001) and high-molecular-weight adiponectin (36% [16, 60];
< 0.001) levels from 0 to 24 weeks.
EMPA effectively reduces hepatic fat in patients with T2D with excellent glycemic control and short known disease duration. Interestingly, EMPA also decreases circulating uric acid and raises adiponectin levels despite unchanged insulin sensitivity. EMPA could therefore contribute to the early treatment of nonalcoholic fatty liver disease in T2D. |
|---|---|
| AbstractList | To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).
Patients with T2D (
= 84) (HbA
6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were randomly assigned to 24 weeks of treatment with 25 mg daily EMPA or placebo. The primary end point was the difference of the change in LFC as measured with magnetic resonance methods from 0 (baseline) to 24 weeks between groups. Tissue-specific insulin sensitivity (secondary outcome) was assessed by two-step clamps using an isotope dilution technique. Exploratory analysis comprised circulating surrogate markers of insulin sensitivity and liver function. Statistical comparison was done by ANCOVA adjusted for respective baseline values, age, sex, and BMI.
EMPA treatment resulted in a placebo-corrected absolute change of -1.8% (95% CI -3.4, -0.2;
= 0.02) and relative change in LFC of -22% (-36, -7;
= 0.009) from baseline to end of treatment, corresponding to a 2.3-fold greater reduction. Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4];
< 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed. EMPA treatment also led to placebo-corrected changes in uric acid (-74 mol/L [-108, -42];
< 0.001) and high-molecular-weight adiponectin (36% [16, 60];
< 0.001) levels from 0 to 24 weeks.
EMPA effectively reduces hepatic fat in patients with T2D with excellent glycemic control and short known disease duration. Interestingly, EMPA also decreases circulating uric acid and raises adiponectin levels despite unchanged insulin sensitivity. EMPA could therefore contribute to the early treatment of nonalcoholic fatty liver disease in T2D. To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).OBJECTIVETo evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).Patients with T2D (n = 84) (HbA1c 6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were randomly assigned to 24 weeks of treatment with 25 mg daily EMPA or placebo. The primary end point was the difference of the change in LFC as measured with magnetic resonance methods from 0 (baseline) to 24 weeks between groups. Tissue-specific insulin sensitivity (secondary outcome) was assessed by two-step clamps using an isotope dilution technique. Exploratory analysis comprised circulating surrogate markers of insulin sensitivity and liver function. Statistical comparison was done by ANCOVA adjusted for respective baseline values, age, sex, and BMI.RESEARCH DESIGN AND METHODSPatients with T2D (n = 84) (HbA1c 6.6 ± 0.5% [49 ± 10 mmol/mol], known disease duration 39 ± 27 months) were randomly assigned to 24 weeks of treatment with 25 mg daily EMPA or placebo. The primary end point was the difference of the change in LFC as measured with magnetic resonance methods from 0 (baseline) to 24 weeks between groups. Tissue-specific insulin sensitivity (secondary outcome) was assessed by two-step clamps using an isotope dilution technique. Exploratory analysis comprised circulating surrogate markers of insulin sensitivity and liver function. Statistical comparison was done by ANCOVA adjusted for respective baseline values, age, sex, and BMI.EMPA treatment resulted in a placebo-corrected absolute change of -1.8% (95% CI -3.4, -0.2; P = 0.02) and relative change in LFC of -22% (-36, -7; P = 0.009) from baseline to end of treatment, corresponding to a 2.3-fold greater reduction. Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4]; P < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed. EMPA treatment also led to placebo-corrected changes in uric acid (-74 mol/L [-108, -42]; P < 0.001) and high-molecular-weight adiponectin (36% [16, 60]; P < 0.001) levels from 0 to 24 weeks.RESULTSEMPA treatment resulted in a placebo-corrected absolute change of -1.8% (95% CI -3.4, -0.2; P = 0.02) and relative change in LFC of -22% (-36, -7; P = 0.009) from baseline to end of treatment, corresponding to a 2.3-fold greater reduction. Weight loss occurred only with EMPA (placebo-corrected change -2.5 kg [-3.7, -1.4]; P < 0.001), while no placebo-corrected change in tissue-specific insulin sensitivity was observed. EMPA treatment also led to placebo-corrected changes in uric acid (-74 mol/L [-108, -42]; P < 0.001) and high-molecular-weight adiponectin (36% [16, 60]; P < 0.001) levels from 0 to 24 weeks.EMPA effectively reduces hepatic fat in patients with T2D with excellent glycemic control and short known disease duration. Interestingly, EMPA also decreases circulating uric acid and raises adiponectin levels despite unchanged insulin sensitivity. EMPA could therefore contribute to the early treatment of nonalcoholic fatty liver disease in T2D.CONCLUSIONSEMPA effectively reduces hepatic fat in patients with T2D with excellent glycemic control and short known disease duration. Interestingly, EMPA also decreases circulating uric acid and raises adiponectin levels despite unchanged insulin sensitivity. EMPA could therefore contribute to the early treatment of nonalcoholic fatty liver disease in T2D. |
| Author | Roden, Michael Katsuyama, Hisayuki Hwang, Jong-Hee Lagerpusch, Merit Kabisch, Stefan Stefan, Norbert Kasperk, Christian Henkel, Elena Kantartzis, Konstantinos Kuss, Oliver Kahl, Sabine Pfeiffer, Andreas Markgraf, Daniel Birkenfeld, Andreas L Gancheva, Sofiya Straßburger, Klaus Wolkersdorfer, Martin F Kopf, Stefan van Gemert, Theresa Knebel, Birgit Herder, Christian Machann, Jürgen Kupriyanova, Yuliya Bornstein, Stefan R |
| Author_xml | – sequence: 1 givenname: Sabine surname: Kahl fullname: Kahl, Sabine organization: German Center for Diabetes Research, München-Neuherberg, Germany – sequence: 2 givenname: Sofiya surname: Gancheva fullname: Gancheva, Sofiya organization: Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany – sequence: 3 givenname: Klaus surname: Straßburger fullname: Straßburger, Klaus organization: Institute for Biometrics and Epidemiology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany – sequence: 4 givenname: Christian orcidid: 0000-0002-2050-093X surname: Herder fullname: Herder, Christian organization: German Center for Diabetes Research, München-Neuherberg, Germany – sequence: 5 givenname: Jürgen surname: Machann fullname: Machann, Jürgen organization: Institute for Diabetes Research and Metabolic Diseases, Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany – sequence: 6 givenname: Hisayuki surname: Katsuyama fullname: Katsuyama, Hisayuki organization: German Center for Diabetes Research, München-Neuherberg, Germany – sequence: 7 givenname: Stefan orcidid: 0000-0002-6455-3769 surname: Kabisch fullname: Kabisch, Stefan organization: Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke, Nuthetal, Germany – sequence: 8 givenname: Elena surname: Henkel fullname: Henkel, Elena organization: Clinical Study Center of Metabolic Vascular Medicine, GWT-TUD GmbH, Dresden, Germany – sequence: 9 givenname: Stefan surname: Kopf fullname: Kopf, Stefan organization: Department of Internal Medicine 1 and Clinical Chemistry, University Hospital of Heidelberg, Heidelberg, Germany – sequence: 10 givenname: Merit surname: Lagerpusch fullname: Lagerpusch, Merit organization: Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbrücke, Nuthetal, Germany – sequence: 11 givenname: Konstantinos surname: Kantartzis fullname: Kantartzis, Konstantinos organization: Institute for Diabetes Research and Metabolic Diseases, Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany – sequence: 12 givenname: Yuliya surname: Kupriyanova fullname: Kupriyanova, Yuliya organization: German Center for Diabetes Research, München-Neuherberg, Germany – sequence: 13 givenname: Daniel surname: Markgraf fullname: Markgraf, Daniel organization: German Center for Diabetes Research, München-Neuherberg, Germany – sequence: 14 givenname: Theresa surname: van Gemert fullname: van Gemert, Theresa organization: Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany – sequence: 15 givenname: Birgit surname: Knebel fullname: Knebel, Birgit organization: Institute for Clinical Biochemistry and Pathobiochemistry, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany – sequence: 16 givenname: Martin F surname: Wolkersdorfer fullname: Wolkersdorfer, Martin F organization: Landesapotheke Salzburg, Salzburg, Austria – sequence: 17 givenname: Oliver orcidid: 0000-0003-3301-5869 surname: Kuss fullname: Kuss, Oliver organization: Institute for Biometrics and Epidemiology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany – sequence: 18 givenname: Jong-Hee surname: Hwang fullname: Hwang, Jong-Hee organization: German Center for Diabetes Research, München-Neuherberg, Germany – sequence: 19 givenname: Stefan R surname: Bornstein fullname: Bornstein, Stefan R organization: Paul Langerhans Institute Dresden, Helmholtz Center Munich at University Hospital MKIII, and Faculty of Medicine, TU Dresden, Dresden, Germany – sequence: 20 givenname: Christian surname: Kasperk fullname: Kasperk, Christian organization: Department of Internal Medicine 1 and Clinical Chemistry, University Hospital of Heidelberg, Heidelberg, Germany – sequence: 21 givenname: Norbert orcidid: 0000-0002-2186-9595 surname: Stefan fullname: Stefan, Norbert organization: Institute for Diabetes Research and Metabolic Diseases, Helmholtz Center Munich at the University of Tübingen, Tübingen, Germany – sequence: 22 givenname: Andreas surname: Pfeiffer fullname: Pfeiffer, Andreas organization: Department of Endocrinology, Diabetes and Nutrition, Campus Benjamin Franklin, Charité University Medicine, Berlin, Germany – sequence: 23 givenname: Andreas L orcidid: 0000-0003-1407-9023 surname: Birkenfeld fullname: Birkenfeld, Andreas L organization: Institute for Clinical Biochemistry and Pathobiochemistry, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich-Heine University, Düsseldorf, Germany – sequence: 24 givenname: Michael orcidid: 0000-0001-8200-6382 surname: Roden fullname: Roden, Michael email: michael.roden@ddz.de organization: Division of Endocrinology and Diabetology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31540903$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2019 by the American Diabetes Association. |
| Copyright_xml | – notice: 2019 by the American Diabetes Association. |
| DBID | NPM 7X8 |
| DOI | 10.2337/dc19-0641 |
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| Discipline | Medicine |
| EISSN | 1935-5548 |
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| PublicationTitle | Diabetes care |
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| Snippet | To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically... |
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| Title | Empagliflozin Effectively Lowers Liver Fat Content in Well-Controlled Type 2 Diabetes: A Randomized, Double-Blind, Phase 4, Placebo-Controlled Trial |
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