Effect of SGLT-2 inhibitors on arterial stiffness in a real-world setting

Not Applicable

Completed

• Conditions: Arterial stiffness in patients with type 2 diabetes mellitus; Circulatory System

• Registration Number: ISRCTN88851713
• Lead Sponsor: Aristotle University of Thessaloniki

Brief Summary

2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34783355/ (added 15/02/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36143844/ (added 29/09/2022) 2022 Other publications in https://doi.org/10.5114/amsad.2022.116665 Sub-analysis (added 17/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-19
• Study Completion: 2022-05-01
• Last Update Posted: 28 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Male or female
2. Aged 18-75 years old
3. Established diagnosis of type 2 diabetes mellitus (=12 months)
4. HbA1c values 6.5 – 10.0%
5. Stable antidiabetic and antihypertensive treatment over the last 6 months
6. Indication for the initiation or addition of new antidiabetic therapy with an SGLT-2 inhibitor according to the treating physician’s discretion
7. Written informed consent

Exclusion Criteria

1. Type 1 diabetes mellitus
2. History of a serious adverse reaction to an SGLT-2 inhibitor
3. Renal dysfunction (estimated glomerular filtration rate <45 ml/min/1.73 m²)
4. Body mass index greater than 45 kg/m²
5. Uncontrolled hypertension despite optimal treatment (blood pressure =180/110 mmHg)
6. Liver dysfunction
7. Recent revascularization procedure or admission to hospital due to worsening of pre-existing heart failure (during the last 3 months)
8. Recent hospitalization due to diabetic ketoacidosis (during the last 3 months)
9. Alcohol or illicit drug intake
10. Pregnancy, possible pregnancy or breastfeeding
11. Participation of the patient in another clinical study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ambulatory pulse wave velocity (PWV) measured using the Mobilograph device at baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
1. Ambulatory central pulse pressure measured using the Mobilograph device at baseline and after 6 months<br>2. Ambulatory augmentation index measured using the Mobilograph device at baseline and after 6 months<br>3. Rest parameters measured using the Mobilograph device at baseline and after 6 months