Comparison of various methods to measure the endothelial functio

Recruiting

• Conditions: Healthy volunteers; E11; I70; Type 2 diabetes mellitus; Atherosclerosis

• Registration Number: DRKS00022910
• Lead Sponsor: Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria Cohort I (Healthy subjects)
- Age >18 years
- Body mass index in the range of 20.0 – 27.0 kg/m2,
- Fasting plasma glucose or capillary glucose <110mg/dL (without medication)

Inclusion Criteria Cohort II (Subjects with Type 2 Diabetes)
- Age >18 years
- established diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, DPP-4-inhibitors, sulfonylurea or SGLT-2 inhibitors

Inclusion Criteria Cohort III (Subjects with atherosclerotic lesions)
- Age >18 years

Exclusion Criteria

Exclusion criteria cohort I (Healthy subjects)
- History of cardiovascular disease
- Presence of any metabolic disease
- Intake of any glucose lowering, lipid lowering or blood pressure lowering medication
- acute or chronic inflammatory disorder
- heavy drinking (more than 15 drinks/week)
- Known Malignancy
- Intake of illicit substances
- Women who are pregnant, breast-feeding or trying to become pregnant

Exclusion criteria cohort II (Subjects with Type 2 Diabetes)
- acute or chronic inflammatory disorder
- History of cardiovascular disease
- heavy drinking (more than 15 drinks/week)
- Known Malignancy
- Intake of illicit substances
-Women who are pregnant, breast-feeding or trying to become pregnant

Exclusion criteria cohort III (Subjects with atherosclerosis)
- Acute cardiovascular event <3 months
- Established type 2 diabetes mellitus
- acute or chronic inflammatory disorder
- heavy drinking (more than 15 drinks/week)
- Known Malignancy
- Intake of illicit substances
- Women who are pregnant, breast-feeding or trying to become pregnant

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of the study is to calculate the correlation between the measurement of endothelial function using Endo-PAT 2000, Flow Mediated Dilatation, Retinal Vessels Analyzer, Cardio Ankle Vascular Index and pulse wave velocity. The measurements are only carried out at one timepoint and are therefore compared at this point in time.

Secondary Outcome Measures

Name	Time	Method
Correlation between the different methods to measure endothelial function in various cohorts investigated.