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Ertugliflozin: Cardioprotective Effects on Epicardial Fat

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ClinicalTrials.gov Identifier: NCT04167761
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : December 23, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Atherosclerosis Type 2 Diabetes Insulin Resistance Drug: Ertugliflozin Drug: Glipizide Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: unblinded randomized trial
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ertugliflozin Drug: Ertugliflozin
Consenting participants in the Ertugliflozen group will be supplied with 2-week course of medication prior to cardiac surgery. Participants will be educated on use and have blood glucose monitored during the medication course. The surgeon will then collect a small amount of fat near the heart during surgery.
Other Name: SGLT2 inhibitor
Active Comparator: Glipizide Drug: Glipizide
Consenting participants in the Glipizide group will be supplied with 2-week course of medication prior to cardiac surgery. Participants will be educated on use and have blood glucose monitored during the medication course. The surgeon will then collect a small amount of fat near the heart during surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples. [ Time Frame: Time to collect tissue collected during surgery (up to 15 minutes) ]
    Analysis will be performed using Lipolysis Colorimetric Assay and measured by glycerol content on standard curve. Indirect effects of SGLT2i in vivo in epicardial adipose tissue will be compared to Glipizide by measuring rate of lipolysis, or breakdown of adipose in to free fatty acids.


Secondary Outcome Measures :
  1. Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples. [ Time Frame: Time to collect tissue collected during surgery (up to 15 minutes) ]
    Mature adipocytes will be isolated, cultured, and treated with 2-NBDG, a fluorescently-labeled deoxyglucose analog, as a probe for the detection of glucose uptake measured by excitation/emission of florescence in the mature cells.

  2. Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples. [ Time Frame: Time to collect tissue collected during surgery (up to 15 minutes) ]
    Analysis will be performed using Luminex to measure levels of inflammatory cytokines on the human adipocyte panel.

  3. Distribution of adipose cell size in epicardial tissue. [ Time Frame: Time to collect tissue collected during surgery (up to 15 minutes) ]
    After tissue collection and osmium fixation, adipose cell size will be determined by Beckman Coulter Multisizer III, and described via a mathematical model to estimate peak diameter, fat storage capacity, size variability, and % small cells.


Eligibility Criteria
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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:

  • patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery
  • history of Diabetes Mellitus Type 2 currently taking metformin or diet-controlled

Exclusion Criteria:

  • allergy or intolerance to interventional medication
  • currently taking any anti-diabetic medication other than metformin
Contacts and Locations
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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): NCT04167761


Contacts
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Contact: Ekrem M Ayhan, BS (908) 619-5381 ayhane@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Tracey McLaughlin, MD    650-736-2056    tmclaugh@stanford.edu   
Sponsors and Collaborators
Stanford University
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Tracey McLaughlin, MD Stanford University
More Information
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Responsible Party: Tracey McLaughlin, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04167761    
Other Study ID Numbers: 52647
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tracey McLaughlin, Stanford University:
Epicardial Adipose Tissue
SGLT2 Inhibitor
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Ertugliflozin
Sodium-Glucose Transporter 2 Inhibitors
Glipizide
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs