Semaglutide vs Dulaglutide on Epicardial Adipose Tissue

Epicardial Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200625
• Other study ID #: 20190944
• Status: Completed
• Start date: September 24, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: May 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Epicardial Fat

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epicardial Fat thickness	Ultrasound measured Epicardial Fat thickness	12 weeks