Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

NCT04226820 | Unknown DMC

• 1 other identifier: B670201940995
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Vascular Complications; Mitochondrial Diseases

Keywords

diabetes mellitus; muscular oxygenation; vascular function

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Blood pressure analysis

  20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)

Study Arms (1)

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.

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

Interventions

examination: blood pressure assessment OTHER

blood pressure measurement for 30 minutes, dominant side

participant

examination: Flow Mediated Dilatation (FMD)-test OTHER

Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality

participant

examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring OTHER

participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation

participant

examination: measurement of glucose by a finger prick OTHER

follow-up of blood sugar (glucose) during examinations by a finger prick

participant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women
• age 18-85 years old
• diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants

You may not qualify if:

• other types of diabetes mellitus than type 1 or type 2
• alcohol abuse
• active cancer
• pregnancy

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

University Gent, Rehabilitation Sciences

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Mitochondrial Diseases

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Samyah Shadid, Prof. dr.

  University hospital of Ghent and University of Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouk Tanghe, PhD

CONTACT

+32 09 332 36 27; anouk.tanghe@ugent.be

Patrick Calders, Prof. dr.

CONTACT

+32 09 332 69 15; patrick.calders@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 1, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)