Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Mitochondrial Diseases; Vascular Complications

• Registration Number: NCT04226820
• Lead Sponsor: University Ghent

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-02-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Near-infrared spectroscopy during exercise	30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)	analysis of changes in oxygenated blood during exercise
Flow Mediated Dilatation (FMD)-test	20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)	flow mediated dilatation test
exercise test wilt hand held dynamometer	30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)	analysis of strength and exercise capacity

Secondary Outcome Measures

Name	Time	Method
Blood pressure analysis	20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)	measurement of basal blood pressure (systolic and diastolic)

Trial Locations

Locations (1)

University Gent, Rehabilitation Sciences; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium