Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— PREMOD  

Official title:

Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226820
• Other study ID #: B670201940995
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: University Ghent
• Contact: Anouk Tanghe, PhD
• Phone: +32 09 332 36 27
• Email: anouk.tanghe[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Mitochondrial Diseases
• Vascular Complications

Intervention

Other:
• examination: blood pressure assessment
blood pressure measurement for 30 minutes, dominant side
• examination: Flow Mediated Dilatation (FMD)-test
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
• 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
• examination: measurement of glucose by a finger prick
follow-up of blood sugar (glucose) during examinations by a finger prick

Locations

Country	Name	City	State
Belgium	University Gent, Rehabilitation Sciences	Ghent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilatation (FMD)-test	flow mediated dilatation test	20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Primary	Near-infrared spectroscopy during exercise	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)
Primary	exercise test wilt hand held dynamometer	analysis of strength and exercise capacity	30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Secondary	Blood pressure analysis	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)