Semaglutide vs Dulaglutide on Epicardial Adipose Tissue

Effects of Semaglutide vs Dulaglutide on Epicardial Adipose Tissue Thickness in Subjects With Type 2 Diabetes and Obesity

Epicardial Fat (EAT), the visceral fat depot of the heart, is a modifiable cardio-metabolic risk factor and therapeutic target. EAT expresses GLP-1 receptors (GLP-1R). GLP-1 receptor agonist liraglutide is known to significantly decrease EAT thickness. However, the effects of GLP-1 receptor agonists semaglutide and dulaglutide on EAT thickness are unknown

Study Overview

• Status: Completed
• Conditions: Epicardial Fat

Detailed Description

This is a retrospective, observational, case control study. Data were obtained from retrospective review of the electronic medical records.

Patients were treated with either semaglutide, dulaglutide or metformin as standard of care, during routine clinical practice, regardless of the study. Each patient underwent routine labs and an onsite ultrasound measurement of EAT thickness at baseline and at the routine 12-week follow up visit, as standard of care.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic subjects who routinely come to the University of Miami Division of Diabetes, Endocrinology and Metabolism outpatient diabetic clinic, as standard of care.

Description

Inclusion Criteria:

• Type 2 diabetes,
• BMI ≥27 kg/m2,
• Age ≥ 18 years old

Exclusion Criteria:

• Type 1 diabetes
• Concurrent use of dipeptidyl peptidase 4 (DPP-4) inhibitors or other GLP-1 agonist receptors
• History of diabetic ketoacidosis
• Known contraindications to GLP-1 receptor agonists such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of multiple endocrine neoplasia type 2
• Acute infective diseases, cancer or chemotherapy
• Use of systemic corticosteroids within the 3 months prior this study
• Known or suspected allergy to semaglutide or dulaglutide excipients or related products
• Pregnancy, breastfeeding or the intention of becoming pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Semaglutide; Patients using standard of care weekly GLP-1A analog Semaglutide
Dulaglutide; Patients using standard of care weekly GLP-1A analog Dulaglutide
Metformin; Patients using standard of care daily Metformin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epicardial Fat thickness	Ultrasound measured Epicardial Fat thickness	12 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Gianluca Iacobellis, MD PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20190944

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No