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CompletedNCT04200625Updated May 10, 2023

Semaglutide vs Dulaglutide on Epicardial Adipose Tissue

An observational study in Epicardial Fat, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by University of Miami · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
18 Years to 90 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Epicardial Fat
03

In context

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Epicardial Fat thickness

    Ultrasound measured Epicardial Fat thickness

    Time frame: 12 weeks

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Study locations

1 site
  • University of Miami
    Miami, Florida 33136, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04200625
Lead sponsor
University of Miami
Responsible party
Gianluca Iacobellis (Professor of Medicine, University of Miami) — Principal investigator
First posted
Dec 16, 2019
Start date
Sep 24, 2019
Primary completion
Dec 9, 2019
Completion
Dec 9, 2019
Last update
May 10, 2023

Study contacts

Gianluca Iacobellis, MD PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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