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

November 27, 2023 updated by: University Ghent

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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • University Gent, Rehabilitation Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

University Hospital, Ghent

Investigators

  • Principal Investigator: Samyah Shadid, Prof. dr., University hospital of Ghent and University of Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201940995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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