Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus (PREMOD)

University Ghent

Status: Enrolling

Conditions: Vascular Complications; Diabetes Mellitus; Mitochondrial Diseases

Treatments: Other: examination: Flow Mediated Dilatation (FMD)-test; Other: examination: measurement of glucose by a finger prick; Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring; Other: examination: blood pressure assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04226820

B670201940995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• men and women
• age 18-85 years old
• diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants

Exclusion criteria

• other types of diabetes mellitus than type 1 or type 2
• alcohol abuse
• active cancer
• pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

participant

Experimental group

Description:

Participants are divided into 3 groups based on their diagnosis: diabetes mellitus type 1, diabetes mellitus type 2, and healthy persons. Each participant (independent of group) will have the same examinations. There is no retesting of the same participant in other conditions.

Treatment:

Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring

Other: examination: measurement of glucose by a finger prick

Other: examination: blood pressure assessment

Other: examination: Flow Mediated Dilatation (FMD)-test