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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226820
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
University Hospital, Ghent
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Vascular Complications Mitochondrial Diseases 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: There is no masking because the participant knows his diagnosis. Besides, the investigator checks the blood sugar at different times during the examinations, so also the investigator is not blinded. In this study, blinding would have no additional value.
Primary Purpose: Other
Official Title: Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021


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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226820


Contacts
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Contact: Anouk Tanghe, PhD +32 09 332 36 27 anouk.tanghe@ugent.be
Contact: Patrick Calders, Prof. dr. +32 09 332 69 15 patrick.calders@ugent.be

Locations
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Belgium
University Gent, Rehabilitation Sciences
Ghent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
University Ghent
University Hospital, Ghent
Investigators
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Principal Investigator: Samyah Shadid, Prof. dr. University hospital of Ghent and University of Ghent
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04226820    
Other Study ID Numbers: B670201940995
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
diabetes mellitus
muscular oxygenation
vascular function
Additional relevant MeSH terms:
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Diabetes Mellitus
Mitochondrial Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases