Primary outcomeMean· Baseline, 3 months, 6 months and 12 months
Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
| Group | Value (m/s) | Spread |
|---|---|---|
| Liraglutide | 11.8 | 2.5 |
| Metformin | 11.2 | 3 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffects 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
NCTNCT03010683 (opens ClinicalTrials.gov in a new tab)Other idGLP1-DM-ATTIKON
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 60 participants (actual)
- Sponsor
- University of Athens · Other
- Design
- Randomized · Single masking
- Countries
1 country
Greece
- Start
- Nov 2015
- Primary completion
- Jun 2017
- Completion
- Dec 2017
- First posted
- 5 Jan 2017 (estimated)
- Last update posted
- 5 Mar 2021
- Conditions
- Type 2 Diabetes Mellitus · Coronary Artery Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018
- N/A
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
NCT03010683Nov 2015 to Dec 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LiraglutideDrug
- MetforminDrug
Arms2
Active comparator
liraglutide
Active comparator
Metformin
Primary outcomes4
Outcomes the sponsor listed as primary.
Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
Time frame · Baseline, 3 months, 6 months and 12 months
Registry description
Differences in carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.
Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
Time frame · Baseline, 3 months, 6 months, and 12 months.
Registry description
Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.
Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
Time frame · Baseline, 3 months, 6 months, and 12 months.
Registry description
Differences in coronary flow reserve (CFR) using Doppler echocardiography at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.
Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
Time frame · Baseline, 3 months, 6 months, and 12 months.
Registry description
Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. High PBR values represent reduced glycocalyx thickness.
Secondary outcomes(2)
Endothelial Glycocalyx and Pulse Wave Velocity.
Time frame · Baseline, 3 months, 6 months, and 12 months.
Registry description
Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.
Endothelial Glycocalyx and Coronary Flow Reserve.
Time frame · Baseline, 3 months, 6 months, and 12 months.
Registry description
Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with coronary flow reserve (CFR) using Doppler echocardiography at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline, 3 months, 6 months, and 12 months.
Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
| Group | Value (percentage of the central pulse pressure) |
|---|---|
| Liraglutide | 18 |
| Metformin | 14 |
Primary outcome· Baseline, 3 months, 6 months, and 12 months.
Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
| Group | Value |
|---|---|
| Liraglutide | not posted |
| Metformin | not posted |
Primary outcomeMean· Baseline, 3 months, 6 months, and 12 months.
Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.
| Group | Value (micrometers) | Spread |
|---|---|---|
| Liraglutide | 2.1 | 0.29 |
| Metformin | 2.13 | 0.3 |
Secondary and other outcome results(2)
Secondary outcomeNumber· Baseline, 3 months, 6 months, and 12 months.
Endothelial Glycocalyx and Pulse Wave Velocity.
| Group | Value (Pearson correlation coefficient (r)) |
|---|---|
| Liraglutide | 0.39 |
| Metformin | 0.35 |
Secondary outcome· Baseline, 3 months, 6 months, and 12 months.
Endothelial Glycocalyx and Coronary Flow Reserve.
| Group | Value |
|---|---|
| Liraglutide | not posted |
| Metformin | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideStimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection | 0 / 30 | 0 / 30 | 0 / 30 |
| MetforminAntidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os | 0 / 30 | 0 / 30 | 0 / 30 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
9 results
Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes.
Lambadiari et al. 2018Cardiovascular diabetologycited by 127
PMID 29310645PMC5759220DOI 10.1186/s12933-017-0646-zPUB-29310645
CC BY9 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedGnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2. PMID 32501595
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.