NCT04226820

Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Oxygen is required for an optimal muscle function. In patients with diabetes mellitus, hyperglycemia can cause vascular complications. The endothelium (inter layer of the blood vessels) can be damaged leading to a reduced oxygen flow towards the muscle cells. Besides, it is possible that mitochondrial dysfunction is occuring leading to reduced extraction of oxygen. Both conditions will lead to a reduced flow of oxygen towards the muscle and this can have impact on the production of energy necessary for optimal functioning. In this study, the investigators will examine the functionality of the blood vessels (1) and the uptake of oxygen into the muscles (2) in patients with diabetes mellitus type 1 and type 2 (with and without vascular complications) compared to healthy persons.

Detailed description

The investigators plan to recruit in total 125 participants who will be divided into 3 main groups: (I) diabetes mellitus type 1 (with (a) or without (b) vascular complications), (II) diabetes mellitus type 2 (with (a) or without (b) vascular complications), and (III) healthy persons. Diabetes mellitus will be defined by the guidelines of the American Diabetes Association (ADA). The examinations for this study consist of a blood pressure assessment, Flow Mediated Dilatation (FMD)-measurement, and a handgrip exercise test. The protocol will take approximately 2 hours. The investigator who performs the FMD-test followed a course and passed thorough evaluation. The blood pressure assessment will be continuously for 20 minutes to avoid large bias.

Conditions

• Diabetes Mellitus
• Vascular Complications
• Mitochondrial Diseases

Interventions

Type	Name	Description
OTHER	examination: blood pressure assessment	blood pressure measurement for 30 minutes, dominant side
OTHER	examination: Flow Mediated Dilatation (FMD)-test	Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
OTHER	examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring	participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
OTHER	examination: measurement of glucose by a finger prick	follow-up of blood sugar (glucose) during examinations by a finger prick

Timeline

• Start date: 2020-02-01
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2020-01-13
• Last updated: 2023-11-30

Locations

1 site across 1 country: Belgium