Semaglutide vs Dulaglutide on Epicardial Adipose Tissue

NCT04200625 | Completed

• 1 other identifier: 20190944
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epicardial Fat

Outcome Measures

Primary Outcomes (1)

• Epicardial Fat thickness

  Ultrasound measured Epicardial Fat thickness

  12 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Gianluca Iacobellis, MD PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 16, 2019
• Study Start: September 24, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)