To examine whether heating can prevent the hyperglycaemia-induced decline in endothelial function in T2DM and age- and sex-matched controls.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in endothelial function after 75-gr glucose (measured as the
brachial artery flow-mediated dilation at 3 distinct time-points).
Secondary outcome
blood flow (in mL/min)
Background summary
Endothelial dysfunction contributes to the development of vascular
complications in type 2 Diabetes Mellitus (T2DM). Elevation in glucose level
(i.e. hyperglycaemia) is demonstrated to contribute to a transient decrease in
endothelial function, especially in T2DM as these subjects demonstrate
prolonged hyperglycaemia after a glucose load compared to healthy controls.
In previous studies, we have demonstrated that elevation in blood flow can
improve endothelial function in healthy subjects. Accordingly, elevation in
blood flow may also counteract the impact of hyperglycaemia on endothelial
function in T2DM and their age- and sex-matched controls.
Study objective
To examine whether heating can prevent the hyperglycaemia-induced decline in
endothelial function in T2DM and age- and sex-matched controls.
Study design
Cross-sectional observational study
Study burden and risks
We will take a total of four venous blood samples from each subject. Taking a
blood sample is associated with a 5% risk of developing a haemorrhage, which is
not associated with any functional limitations and will disappear within 2
weeks. To minimise the potential risk, a venous *line* is introduced once which
facilitates repeated venous blood withdrawals. Other measures/interventions (75
gr glucose load, heating, echo-Doppler, 5-minutes cuff inflation) are not
associated with any potential health risk.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
Diabetes group:
- Older than 40 years
- Diagnosed with type 2 diabetes mellitus at least 2 years ago
Control group:
- Older than 40 years
Exclusion criteria
Diabetes group:
- Women
- Cardiovascular disease
- Hypercholesterolemia
- Hypertension (>160 mmHg systolic and/or >90 mmHg diastolic pressure) and/or subjects on antihypertensive drugs
- Smoking
- Type I diabetes mellitus
- Older than 70 years
- Subjects with vascular complications due to type 2 diabetes mellitus (e.g. diabetic foot ulcer);Control group:
- Women
- Cardiovascular disease
- Hypercholesterolemia
- Hypertension (>160 mmHg systolic and/or >90 mmHg diastolic pressure) and/or subjects on antihypertensive drugs
- Smoking
- Older than 70 years
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 | NL47169.091.13 |