Epicardial FatNCT04200625
Semaglutide vs Dulaglutide on Epicardial Adipose Tissue
An observational study of Epicardial Fat, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epicardial Fat
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 9 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Type 2 diabetes,
- BMI ≥27 kg/m2,
- Age ≥ 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Epicardial Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Epicardial Fat thickness
Ultrasound measured Epicardial Fat thickness
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start24 Sep 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicardial FatStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Iacobellis, University of Miami
- Investigators
- Gianluca Iacobellis, MD PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200625
- Sponsor's protocol ID
- 20190944
- Status last verified
- May 2023
- First submitted
- 10 Dec 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Semaglutide vs Dulaglutide on Epicardial Adipose Tissue Thickness in Subjects With Type 2 Diabetes and Obesity
- ClinicalTrials.gov ID
- NCT04200625
- Acronym / sponsor ID
- 20190944
- Conditions
- Epicardial Fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Type 2 diabetes,
- BMI ≥27 kg/m2,
- Age ≥ 18 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epicardial Fat thickness
Time frame: 12 weeks
Ultrasound measured Epicardial Fat thickness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Related trials for Epicardial Fat
RecruitingObservational study
Epicardial Fat Tissue and Cardiometabolic Risk in Russian and Asian Populations
Epicardial Fat Tissue (EFT), Chronic Non-Communicable Diseases (NCDs)
RecruitingPhase 3
Epicardial Cardiac Fat-CT (EPIC-CT)
STEMI - ST Elevation Myocardial Infarction, Epicardial Fat
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluca Iacobellis, MD PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epicardial Fat, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial Fat thickness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.