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Dapagliflozin Effects on Epicardial Fat

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: NCT02235298
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Gianluca Iacobellis, University of Miami

Brief Summary:

Dapagliflozin is a new and emerging anti-diabetes medication. Dapagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a consistent associated finding. Because dapagliflozin increases urinary glucose excretion, weight loss could result from reduced body fat secondary to caloric loss or from fluid loss secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether Dapaglifozin may cause a reduction in visceral fat is unknown.

Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin causes a rapid and significant reduction of the epicardial fat, the visceral fat of the heart, in type 2 diabetic patients.

This hypothesis would be tested in a prospective interventional study in 100 overweight or obese type 2 diabetes subjects.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dapagliflozin Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin
Dapaglifozin will be administered the dose of 5 mg once daily. Metformin regimen will be continued.
Drug: Dapagliflozin
Dapaglifozin causes a rapid and significant reduction of epicardial fat in type 2 diabetic patients

Drug: Metformin
Active Comparator: Metformin
Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl.
Drug: Metformin



Primary Outcome Measures :
  1. Epicardial fat Thickness [ Time Frame: 6 months ]
    Epicardial fat thickness will be measured with echocardiography according to the method described and validated by Iacobellis et al



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Type 2 diabetes, as defined by ADA criteria

    • HbA1c ≤ 8% measured at least 1 week prior to the study
    • BMI ≥27 kg/m2
    • Pre-treatment with Metformin as monotherapy
    • Age > 18 and < 70 years old

Exclusion Criteria:

  • • Known contra-indications to Farxiga, in accordance with risks and safety information included in the latest updated Prescribing Information

    • Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
    • Insulin dependent or treated type 2 diabetes
    • Current use of other SGLT2 inhibitors, GLP- 1 analogs or DPP4 inhibitors
    • Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
    • Patients with poor glycemic control will be excluded to maximize long-term patient retention without need
    • History of diabetes ketoacidosis
    • Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
    • Clinical or laboratory evidences of chronic active liver diseases
    • Acute or chronic infective diseases
    • Cancer or chemotherapy
    • Current use of systemic corticosteroids or in the 3 months prior this study
    • Known or suspected allergy to Dapaglifozin, excipients, or related products
    • Pregnant, breast-feeding or the intention of becoming pregnant
    • Females of childbearing potential who are not using adequate contraceptive methods

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): NCT02235298


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Responsible Party: Gianluca Iacobellis, Professor of Clinical Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02235298    
Other Study ID Numbers: 20140671
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Keywords provided by Gianluca Iacobellis, University of Miami:
epicardial fat
diabetes
dapagliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action