N/A
N=60
Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus
Type 2 Diabetes Mellitus · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03010683 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. — 11.8; 11.2; 11.6; 11.5 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liraglutide (Drug); Metformin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Athens
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. |
11.8; 11.2; 11.6; 11.5; 10.3; 11 | — |
| PRIMARY Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. |
18; 14; 15.8; 13.6; 13; 15 | — |
| PRIMARY Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. |
— | — |
| PRIMARY Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. |
2.1; 2.13; 2.07; 2.15; 2.5; 2.13 | — |
| SECONDARY Endothelial Glycocalyx and Pulse Wave Velocity. |
0.39; 0.35; 0.36; 0.32; 0.32; 0.29 | — |
| SECONDARY Endothelial Glycocalyx and Coronary Flow Reserve. |
— | — |
Summary
Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. Agonists of Glucagon like peptide - 1 receptors (GLP-1R) used in the treatment of type 2 diabetes mellitus (T2DM). This category includes exenatide and liraglutide. These drugs lower glucose levels by inhibiting the secretion of glucagon, promoting the release of insulin in response to hyperglycemia, slowing gastric emptying, and augmenting satiety. Clinical studies have shown that GLP-1R agonists have beneficial effects on cardiovascular function in both diabetic patients and healthy subjects. The purpose of this study is to investigate in patients with T2DM without coronary artery disease (CAD), patients with T2DM and CAD and obese patients with abnormal oral glucose tolerance test (OGTT), changes in arterial stiffness, endothelial glycocalyx thickness and coronary reserve flow (CFR) after treatment with metformin or agonist GLP-1R.
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD)
- Patients with T2DM and CAD.
- Obese patients (BMI >30 Kg/m²) with abnormal oral glucose tolerance test (OGTT)
Exclusion Criteria
- valvular heart disease
- congestive heart failure
- peripheral vascular disease
- liver or kidney failure
- history of alcohol or drug abuse
Data sourced from ClinicalTrials.gov (NCT03010683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.