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ID
Source
Brief title
Health condition
post-prandiale endotheel dysfunctie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in endothelial function (measured as flow-mediatd dilation) after a meal (induced by 75-gr glucose ingestion)
Secondary outcome
Blood flow and skin temperature changs
Background summary
Rationale:
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-matched controls.
Objectives:
To examine whether heating can prevent the hyperglycaemia-induced decline in endothelial function in T2DM and age -matched controls.
Study design:
Cross-sectional observational study
Study population:
10 subjects with T2DM and 10 age -matched controls
Intervention (if applicable):
Not applicable
Main study parameters/endpoints:
The change in endothelial function after 75-gr glucose (measured as the brachial artery flow-mediated dilation at 3 distinct time-points).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
Study objective
Warmte zorgt voor toename van de doorbloeding, welke lokaal een afname van de endotheelfunctie na een maaltijd kan voorkomen.
Study design
Before and after (1, 2 and 2.5 h) 75-gr glucose
Intervention
Local heating
Dick H.J. Thijssen
Nijmegen 6525 EX
The Netherlands
+31 (0)24 3614222
d.thijssen@fysiol.umcn.nl
Dick H.J. Thijssen
Nijmegen 6525 EX
The Netherlands
+31 (0)24 3614222
d.thijssen@fysiol.umcn.nl
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 (ensure matching with diabetes group at group level)
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)
- Subjects using insulin injections to regulate glucose homeostasis
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 |
---|---|
NTR-new | NL4513 |
NTR-old | NTR4631 |
Other | CMO : 2013-536 |