Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus (PREMOD)
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anouk Tanghe, PhD
- Phone Number: +32 09 332 36 27
- Email: anouk.tanghe@ugent.be
Study Contact Backup
- Name: Patrick Calders, Prof. dr.
- Phone Number: +32 09 332 69 15
- Email: patrick.calders@ugent.be
Study Locations
-
-
Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Recruiting
- University Gent, Rehabilitation Sciences
-
Contact:
- Anouk Tanghe, PhD
- Phone Number: +32 9 332 36 27
- Email: anouk.tanghe@ugent.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: participant
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.
|
blood pressure measurement for 30 minutes, dominant side
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
follow-up of blood sugar (glucose) during examinations by a finger prick
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flow Mediated Dilatation (FMD)-test
Time Frame: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
|
flow mediated dilatation test
|
20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
|
|
Near-infrared spectroscopy during exercise
Time Frame: 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
|
30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
|
|
exercise test wilt hand held dynamometer
Time Frame: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
|
analysis of strength and exercise capacity
|
30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure analysis
Time Frame: 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)
|
20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Samyah Shadid, Prof. dr., University hospital of Ghent and University of Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201940995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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