Diabetes MellitusPREMODNCT04226820
Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
A study testing examination: blood pressure assessment, examination: Flow Mediated Dilatation (FMD)-test and examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring in people with Diabetes Mellitus and Vascular Complications, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Vascular Complications, Mitochondrial Diseases
- What is being tested?
- examination: blood pressure assessment, examination: Flow Mediated Dilatation (FMD)-test and examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2020to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women
- age 18-85 years old
- diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants
Who cannot join
- other types of diabetes mellitus than type 1 or type 2
- alcohol abuse
- active cancer
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Gent, Rehabilitation Sciences
Ghent, Oost-Vlaanderen, 9000
Anouk Tanghe, PhD, +32 9 332 36 27, anouk.tanghe@ugent.be
About this study
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.
Read the 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.
- Being tested
- examination: blood pressure assessment, examination: Flow Mediated Dilatation (FMD)-test, examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring, examination: measurement of glucose by a finger prick
- Keywords
- diabetes mellitus, muscular oxygenation, vascular function
- Medical subject headings
- Diabetes Mellitus, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
examination: blood pressure assessmentOther
blood pressure measurement for 30 minutes, dominant side
examination: Flow Mediated Dilatation (FMD)-testOther
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoringOther
participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
examination: measurement of glucose by a finger prickOther
follow-up of blood sugar (glucose) during examinations by a finger prick
| Study group | Role | What they receive |
|---|---|---|
| participant | Experimental | 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. Receives: Other: examination: blood pressure assessment; Other: examination: Flow Mediated Dilatation (FMD)-test; Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring; Other: examination: measurement of glucose by a finger prick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilatation (FMD)-test
flow mediated dilatation test
Measured: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Near-infrared spectroscopy during exercise
analysis of changes in oxygenated blood during exercise
Measured: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
exercise test wilt hand held dynamometer
analysis of strength and exercise capacity
Measured: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Secondary outcomes (1)
Blood pressure analysis
measurement of basal blood pressure (systolic and diastolic)
Measured: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Feb 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Samyah Shadid, Prof. dr., Principal investigator, University hospital of Ghent and University of Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226820
- Sponsor's protocol ID
- B670201940995
- Acronym
- PREMOD
- Status last verified
- Nov 2023
- First submitted
- 8 Jan 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04226820
- Acronym / sponsor ID
- PREMOD / B670201940995
- Keywords
- diabetes mellitus, muscular oxygenation, vascular function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| participant | Experimental | Other: examination: blood pressure assessment, Other: examination: Flow Mediated Dilatation (FMD)-test, Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring, Other: examination: measurement of glucose by a finger prickParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women
- age 18-85 years old
- diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants
Key exclusion criteria (4 listed)
- other types of diabetes mellitus than type 1 or type 2
- alcohol abuse
- active cancer
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| examination: blood pressure assessmentblood pressure measurement for 30 minutes, dominant side | Other | participant |
| examination: Flow Mediated Dilatation (FMD)-testFlow Mediated Dilatation (FMD)-test for measuring the endothelial functionality | Other | participant |
| examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoringparticipant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation | Other | participant |
| examination: measurement of glucose by a finger prickfollow-up of blood sugar (glucose) during examinations by a finger prick | Other | participant |
Primary outcome
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
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
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
1 secondary outcome
Blood pressure analysis
Time frame: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samyah Shadid, Prof. dr. principal investigator
University hospital of Ghent and University of Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing examination: blood pressure assessment, examination: Flow Mediated Dilatation (FMD)-test and examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring in people with Diabetes Mellitus and Vascular Complications, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anouk Tanghe, PhD (+32 09 332 36 27, anouk.tanghe@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Mediated Dilatation (FMD)-test (time frame: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.