NCT04744636

Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus

Target Involvement and Exploratory Biomarkers Investigations in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients.

Detailed description

The present interventional study will be performed in 3 groups of healthy volunteers of different ages and in type 2 diabetic patients without an investigational medicinal product administrated.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Other	Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP) : * Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function. * Adenosine : administered intravenously during MRI for the measurement of CFR.
DRUG	Other	Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP): * Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function. * Adenosine : administered intravenously during MRI for the measurement of CFR.

Timeline

• Start date: 2017-04-03
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2021-02-09
• Last updated: 2024-07-25

Locations

1 site across 1 country: Germany