- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167761
Ertugliflozin: Cardioprotective Effects on Epicardial Fat
August 10, 2023 updated by: Tracey McLaughlin, Stanford University
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ekrem M Ayhan, BS
- Phone Number: (908) 619-5381
- Email: ayhane@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ertugliflozin
Ertugliflozin, also known as Steglatro, will be administered once daily for 5 days at a dose of 15mg orally.
|
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 Names:
|
Active Comparator: Glipizide
Glipizide will be randomized to either 2.5mg or 5mg oral dose once daily for 5 days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Time to collect tissue collected during surgery (up to 15 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Time to collect tissue collected during surgery (up to 15 minutes)
|
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.
|
Time to collect tissue collected during surgery (up to 15 minutes)
|
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.
|
Time to collect tissue collected during surgery (up to 15 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tracey McLaughlin, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Hyperinsulinism
- Cardiovascular Diseases
- Insulin Resistance
- Atherosclerosis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Glipizide
- Ertugliflozin
- Sodium-Glucose Transporter 2 Inhibitors
Other Study ID Numbers
- 52647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
Morehouse School of MedicineNot yet recruiting
-
Yonsei UniversityRecruitingCardiovascular DiseaseKorea, Republic of
-
Nanjing Medical UniversityNot yet recruitingCardiovascular Disease
Clinical Trials on Ertugliflozin
-
Merck Sharp & Dohme LLCPfizerActive, not recruitingType 2 Diabetes MellitusUnited States, Belgium, Canada, Colombia, Costa Rica, Dominican Republic, France, Guatemala, Hungary, Israel, Italy, Malaysia, Mauritius, Mexico, Philippines, Poland, Russian Federation, Saudi Arabia, Turkey, Ukraine, United Arab... and more
-
Merck Sharp & Dohme LLCPfizerCompleted
-
Merck Sharp & Dohme LLCPfizerCompleted
-
Merck Sharp & Dohme LLCPfizerCompletedType 2 Diabetes Mellitus
-
Merck Sharp & Dohme LLCPfizerCompleted
-
Merck Sharp & Dohme LLCPfizerCompletedType 2 Diabetes Mellitus | Hepatic Impairment
-
Merck Sharp & Dohme LLCPfizerCompleted
-
Aga Khan UniversityCompletedHypertension | Diabetes Mellitus | Hypercholesterolemia | Metabolic Syndrome XPakistan
-
Merck Sharp & Dohme LLCPfizerCompleted
-
Merck Sharp & Dohme LLCPfizerCompleted