We will enable CEUS measurements of forearm skeletal muscle and determine the intra-observer and day-to-day variability in CEUS measurements.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Intra-observer variability and day-to-day variation of forearm skeletal
muscle CEUS measurements.
2. The percentage change in microvascular blood volume (MBV), flow and flow
velocity (MFV), measured by means of CEUS signal, in forearm skeletal muscle
from baseline to post-exercise status.
Secondary outcome
1. Inter-observer variability in offline analysis of CEUS measurements.
2. Skeletal muscle microvascular flow distribution.
3. Change in skeletal muscle microvascular flow distribution from baseline to
post-exercise status.
Background summary
Obesity is increasingly prevalent and is associated with insulin resistance and
an increased risk for the development of type 2 diabetes and cardiovascular
diseases. Furthermore, subjects with type 2 diabetes or obesity tend to develop
hypertension, which is also a major determinant of cardiovascular morbidity and
mortality. Although the mechanisms underlying the intertwined relationship
among diabetes, hypertension, and cardiovascular events remain to be defined,
microvascular insulin resistance and microvascular dysfunction have been
implicated as a major culprit. A multitude of different techniques exist to
assess microvascular function, all with their own advantages and disadvantages.
Over the past years, the department of internal medicine has performed several
research protocols for microvascular studies using a variety of techniques.
Among these are capillary videomicroscopy, laser Doppler flowmetry and
vasomotion analysis. The major drawback of these methods is, however, the fact
that they only enable measurement of the skin microcirculation. Yet when it
comes to insulin mediated glucose uptake and insulin mediated vasodilation, the
skeletal muscle is the primary organ of interest.
In the past few years a new non-invasive technique has been developed to
measure skeletal muscle perfusion with ultrasound. The contrast enhanced
ultrasound method (CEUS), uses echogenic microbubbles as a contrast agent.
Because of their size, these gas filled lipid bubbles behave like erythrocytes
and are thus able to traverse the smallest capillaries.
Although earlier studies showed a correlation between skin and skeletal muscle
responses to (insulin-augmented) peak reactive hyperaemia, the main interest is
to measure microvascular function directly in skeletal muscle.
Study objective
We will enable CEUS measurements of forearm skeletal muscle and determine the
intra-observer and day-to-day variability in CEUS measurements.
Study design
This study is designed to determine reproducibility of forearm skeletal muscle
CEUS measurements.
Study burden and risks
The objective of this protocol is to study the reproducibility of the CEUS
technique. The most important risks of participation to this study are the
(rare) side-effects of the contrast agent (SonoVue(R)), namely (in 1 to 10% of
studies): headache, facial flushing, nausea, dizziness, (moderate) hypotension,
injection site pain and injection site reactions (bruising, burning and
paraesthesia). In a post marketing study, serious adverse events occurred in
0.009% of patients. The serious adverse events consisted of dyspnea,
bronchospasm, bradycardia, clouding of consciousness, back pain, severe
hypotension, and cutaneous rash. All serious adverse events resolved within 30
minutes after administration of medication (adrenaline, antihistamines,
corticosteroids). No mortalities were reported.
Volunteers will have no direct health benefit by participating in this study.
As a compensation for their time and effort, as well as the burden of the
invasive procedures, subjects will receive a fee of ยค60,= upon completion of
both study days.
Universiteitssingel 50
Maastricht 6200 MD
NL
Universiteitssingel 50
Maastricht 6200 MD
NL
Listed location countries
Age
Inclusion criteria
1. Age 18-55 years
2. BMI < 25 kg/m2 *;* = most likely to have intact capillary recruitment in skeletal muscle (a parameter studied in this research protocol).
Exclusion criteria
1. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure, cardiac shunts, heart valve replacement, pulmonary hypertension).
2. Pulmonary disease.
3. Diabetes mellitus (FPG > 7.8 mmol/L).
4. Smoking.
5. Hypertension (>140/90 mmHg).
6. Alcohol use > 4 U/day.
7. Use of medication (antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin).
8. Pregnancy or lactation.
9. Insufficient knowledge of the Dutch language.
10. Known allergic reaction to ultrasound contrast-agent.
11. Known cardiac dysrhythmias (e.g. atrial fibrillation, long QT-syndrome) or a family history of cardiac dysrhythmias or sudden cardiac death.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37229.068.12 |