Trial Outcomes & Findings for 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 (NCT NCT03010683)

NCT ID: NCT03010683

Last Updated: 2021-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline, 3 months, 6 months and 12 months

Results posted on

2021-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Liraglutide Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection	Metformin Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide n=30 Participants Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection	Metformin n=30 Participants Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Greeks	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Pulse Wave Velocity	11.8 m/s STANDARD_DEVIATION 2.5 • n=5 Participants	11.2 m/s STANDARD_DEVIATION 3 • n=7 Participants	11.5 m/s STANDARD_DEVIATION 2.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months and 12 months

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.

Outcome measures

Outcome measures
Measure	Liraglutide n=30 Participants Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection	Metformin n=30 Participants Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. Baseline	11.8 m/s Standard Deviation 2.5	11.2 m/s Standard Deviation 3
Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 3 months	11.6 m/s Standard Deviation 2.8	11.5 m/s Standard Deviation 2.7
Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 6 months	10.3 m/s Standard Deviation 3.3	11 m/s Standard Deviation 3
Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 12 months	10.5 m/s Standard Deviation 1.9	10.8 m/s Standard Deviation 2

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months, and 12 months.

Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R.

Outcome measures

Outcome measures
Measure	Liraglutide n=30 Participants Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection	Metformin n=30 Participants Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. Baseline	18 percentage of the central pulse pressure Interval -1.0 to 31.0	14 percentage of the central pulse pressure Interval -9.0 to 24.0
Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 3 months	15.8 percentage of the central pulse pressure Interval -2.0 to 29.0	13.6 percentage of the central pulse pressure Interval -6.0 to 25.0
Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 6 months	13 percentage of the central pulse pressure Interval -2.0 to 31.0	15 percentage of the central pulse pressure Interval -8.0 to 24.0
Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 12 months	13.9 percentage of the central pulse pressure Interval -1.0 to 32.0	15.3 percentage of the central pulse pressure Interval -6.0 to 24.0

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months, and 12 months.

Population: The investigators did not measure coronary flow reserve (CFR).

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months, and 12 months.

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.

Outcome measures

Outcome measures
Measure	Liraglutide n=30 Participants Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection	Metformin n=30 Participants Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. Baseline	2.1 micrometers Standard Deviation 0.29	2.13 micrometers Standard Deviation 0.3
Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 3 months	2.07 micrometers Standard Deviation 0.3	2.15 micrometers Standard Deviation 0.3
Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 6 months	2.5 micrometers Standard Deviation 0.2	2.13 micrometers Standard Deviation 0.3
Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. 12 months	2.04 micrometers Standard Deviation 0.2	2.10 micrometers Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, and 12 months.

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.

Outcome measures

Outcome measures
Measure	Liraglutide n=30 Participants Stimulation of glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8 mg once daily as a subcutaneous injection	Metformin n=30 Participants Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
Endothelial Glycocalyx and Pulse Wave Velocity. Baseline	0.39 Pearson correlation coefficient (r)	0.35 Pearson correlation coefficient (r)
Endothelial Glycocalyx and Pulse Wave Velocity. 3 months	0.36 Pearson correlation coefficient (r)	0.32 Pearson correlation coefficient (r)
Endothelial Glycocalyx and Pulse Wave Velocity. 6 months	0.32 Pearson correlation coefficient (r)	0.29 Pearson correlation coefficient (r)
Endothelial Glycocalyx and Pulse Wave Velocity. 12 months	0.44 Pearson correlation coefficient (r)	0.37 Pearson correlation coefficient (r)

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, and 12 months.

Population: The investigators did not estimate the association between endothelial glycocalyx thickness and coronary flow reserve (CFR) because they did not measure the CFR.

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.

Outcome measures

Outcome data not reported

Adverse Events

Liraglutide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ignatios Ikonomidis

2nd Cardiology Department, National and Kapodistrian University of Athens, Attikon Hospital

Phone: +30 6944805732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place