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

Primary Purpose

Diabetes Mellitus, Vascular Complications, Mitochondrial Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
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
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus focused on measuring diabetes mellitus, muscular oxygenation, vascular function

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Gent, Rehabilitation SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

participant

Arm 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.

Outcomes

Primary Outcome Measures

Flow Mediated Dilatation (FMD)-test
flow mediated dilatation test
Near-infrared spectroscopy during exercise
analysis of changes in oxygenated blood during exercise
exercise test wilt hand held dynamometer
analysis of strength and exercise capacity

Secondary Outcome Measures

Blood pressure analysis
measurement of basal blood pressure (systolic and diastolic)

Full Information

First Posted
January 8, 2020
Last Updated
November 25, 2022
Sponsor
University Ghent
Collaborators
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04226820
Brief Title
Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Acronym
PREMOD
Official Title
Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Vascular Complications, Mitochondrial Diseases
Keywords
diabetes mellitus, muscular oxygenation, vascular function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
participant
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
examination: blood pressure assessment
Intervention Description
blood pressure measurement for 30 minutes, dominant side
Intervention Type
Other
Intervention Name(s)
examination: Flow Mediated Dilatation (FMD)-test
Intervention Description
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
Intervention Type
Other
Intervention Name(s)
examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring
Intervention Description
participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
Intervention Type
Other
Intervention Name(s)
examination: measurement of glucose by a finger prick
Intervention Description
follow-up of blood sugar (glucose) during examinations by a finger prick
Primary Outcome Measure Information:
Title
Flow Mediated Dilatation (FMD)-test
Description
flow mediated dilatation test
Time Frame
20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Title
Near-infrared spectroscopy during exercise
Description
analysis of changes in oxygenated blood during exercise
Time Frame
30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Title
exercise test wilt hand held dynamometer
Description
analysis of strength and exercise capacity
Time Frame
30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Secondary Outcome Measure Information:
Title
Blood pressure analysis
Description
measurement of basal blood pressure (systolic and diastolic)
Time Frame
20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anouk Tanghe, PhD
Phone
+32 09 332 36 27
Email
anouk.tanghe@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Calders, Prof. dr.
Phone
+32 09 332 69 15
Email
patrick.calders@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samyah Shadid, Prof. dr.
Organizational Affiliation
University hospital of Ghent and University of Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Gent, Rehabilitation Sciences
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anouk Tanghe, PhD
Phone
+32 9 332 36 27
Email
anouk.tanghe@ugent.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

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