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Cardiovascular Effects of Empagliflozine (EMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918591
Recruitment Status : Unknown
Verified October 2017 by Daniela Jakubowicz, Tel Aviv University.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University

Brief Summary:

It has been shown that in patients with type 2 diabetes (T2D) at high risk for cardiovascular disease (CVD) who received Empagliflozine as compared with placebo had a lower rate of death from cardiovascular causes, non-fatal MI, or non-fatal strokes as well as death from any cause and hospitalization for heart failure.

This lower incidence of cardiovascular disease in individuals treated with selective inhibitor of renal sodium-glucose co-transporters (SGLTs) has been associated with reduction of blood levels of fibroblast growth factor 23 (FGF23) and with increase of blood levels of Klotho.

Therefore we will investigate the blood levels of fibroblast growth factor 23 (FGF23) and of Klotho in type 2 diabetic patients treated with Empagliflozine The investigators anticipate that patients treated with Empagliflozine will have decreased levels of FGF23 and increased levels of Klotho which would provide a good explanation for the beneficial cardiovascular effects of selective inhibitors of renal sodium-glucose co-transporters (SGLTs)


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Empagliflozine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Physiological and Cardiovascular Effects of Empagliflozine in Type 2 Diabetes
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Empagliflozine
All type 2 diabetic participant will be treated during 2 month with Empagliflozine 10 to 25 mg daily during 2 month.
Drug: Empagliflozine
All 6type 2 diabetic participant will receive treatment with Empagliflozine during 2 month
Other Name: EMP




Primary Outcome Measures :
  1. Change of Soluble Klotho [ Time Frame: up to 2 months ]
    The blood levels of soluble Klotho will be quantified at baseline after one month and after two month of treatments with Empagliflozine


Secondary Outcome Measures :
  1. Change of Fibroblast growth factor 23 (FGF23) [ Time Frame: up to 2 months ]
    The blood levels of FGF23 will be quantified at baseline after one month and after two month of treatment with Empagliflozine

  2. Change of 1,25 (OH)Vit D [ Time Frame: up to 2 months ]
    The blood levels of 1,25 (OH)Vit D will be quantified at baseline after one month and after two month of treatment with Empagliflozine

  3. Change of Parathyroid Hormone (PTH) [ Time Frame: up to 2 months ]
    The blood levels of PTH will be quantified at baseline after one month and after two month of treatment with Empagliflozine

  4. Change of Glomerular Filtration Rate (eGFR) [ Time Frame: up to 2 months ]
    The levels of eGFR will be quantified at baseline after one month and after two month of treatment with Empagliflozine

  5. Change of Blood Chemistry [ Time Frame: up to 2 months ]
    The blood chemistry will be quantified at baseline after one month and after two month of treatment with Empagliflozine

  6. Change of HbA1c [ Time Frame: up to 2 months ]
    HbA1c will be quantified at baseline after one month and after two month of treatment with Empagliflozine



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes
  • HbA1C:7.5-10.
  • Age>18 years-80 years
  • Cardiovascular risk factor: Ischemic heart disease (IHD)
  • Status Post Myocardial Infarct (SPMI),
  • Angina Pectoris (AP), stable, unstable AP, Peripheral vascular disease (PVD),
  • Cerebro vascular accident (CVA), all > 6 month
  • Chronic renal failure (CRF),
  • e-GFR > 50 ml/min
  • Patients will be required to be on stable glucose-lowering therapy for at least 12 weeks before entering the study.

Exclusion Criteria:

  • Age<18 years
  • Pregnanacy,breast-feeding.
  • eGFR < 45mg/dl
  • Type1 Diabetes
  • Active urogenital infection , or an infection in the last 6 months.
  • Recurrent UTI or genital infections.
  • SGLT2 treatment.
  • History of ketoacidosis.
  • Pulmonary embolism/DVT during the last year.
  • Malignancy active, (during the last 10 years).
  • Steroid use.

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): NCT02918591


Contacts
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Contact: Julio Wainstein, MD 972506296940 vainstein@wmc.gov.il
Contact: Daniela Jakubowicz 508105552 daniela.jak@gmail.com

Sponsors and Collaborators
Tel Aviv University
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Responsible Party: Daniela Jakubowicz, Professor, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02918591    
Other Study ID Numbers: 0049-16 WOMC
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases