To study the effect of transient high blood glucose level on the brachial artery FMD response, and to determine the reproducibility of the measurements and observed effect.
ID
Source
Brief title
Condition
- Diabetic complications
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FMD, local brachial artery pressure and cyclic change in diameter (distension)
as a function of blood glucose en insulin concentrations.
Secondary outcome
Correlations of selected biomarkers of endothelial function with mentioned
primary study parameters. Also changes therein as a function of blood glucose
en insulin concentrations.
Background summary
Cardiovascular complications play an important role in diabetes mellitus. These
problems are mainly caused by vascular dysfunction. Normally, an artery dilates
in response to an increased blood flow through it, which is known as
flow-mediated dilation (FMD). FMD is blunted or absent in people with diabetes.
However, it is not yet clear how exactly an elevated blood glucose level causes
vascular dysfunction. In healthy volunteers, it remains to be investigated what
the effect of a transiently increased blood glucose level is on the FMD
response. This is partly due to the fact that measuring FMD is technically
challenging. Recently, sensitive methods have become available to assess
brachial artery FMD non-invasively. Accurate measurement of the effect of a
high blood glucose level on FMD may contribute to improved diagnosis of
vascular dysfunction in diabetic and obese patients. In this study, blood
biomarkers of endothelial function are also taken into account to determine
possible correlations between those biomarkers and FMD, as function of blood
glucose.
Study objective
To study the effect of transient high blood glucose level on the brachial
artery FMD response, and to determine the reproducibility of the measurements
and observed effect.
Study design
In 30 healthy volunteers multiple FMD measurements are performed: 2 times under
baseline conditions, plus 30 and 75 minutes after intake of a standardized
glucose-solution. Herewith, we are able to determine whether or not and what
kind of effect an elevated blood glucose level (i.e. via insulin) has on
brachial artery reactivity over time. This entire measurement session is
repeated after about one week to see whether effects are reproducible.
Study burden and risks
Time investment is considerable, given the repeated session a week later (2
times 3 hours, within 1-2 weeks). Measurements are non-invasive, apart from
blood sampling and oral glucose tolerance test (OGTT). The latter two are
routinely used clinically. Complications and risks thereof can be managed
reasonably well by planned procedures and precautions: A. There is a small risk
of bleeding and infections with/after blood sampling, which are minimized by
applied pressure on the wound and sterile materials and needle insertion and
removal. B. After measurements, hypoglycemia (blood glucose dipping) might
occur. Study subjects are therefore prompted to eat something after
measurements. Psychological stress is anticipatedly minor, considering previous
experience in volunteers and patients.
13 Septemberstraat 5
6226 CK Maastricht
Nederland
13 Septemberstraat 5
6226 CK Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
male, aged 18+, fasting glucose below 6.1 mmol/l (point-of-care blood test, see E.6, item 2.)
Exclusion criteria
Female
Non-compliance with one of the following fasting requirements 12 hours prior to measurement:
* Medication
* Smoking
* Caffeine
* Vitamin supplements
* Exercise
* Food and drinks (only water permitted till 3 hours prior to measurements)
Fasting blood glucose level higher than 6.1 mmol/l (point-of-care meter; capillary blood sample).
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 | NL33485.068.10 |