We aim to study the short-term effects of postprandial hyperglycemia in patients with impaired fasting glucose and in patients with T2DM on aortic stiffness as measured by PWV. Secondly, we study the effects of postprandial hyperglycemia on the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pulse Wave Velocity
Secondary outcome
Heart Rate variability
Glucose and insulin levels
Cardiac function
Background summary
Type 2 diabetes mellitus (T2DM) is associated with high mortality and morbidity
due to cardiovascular complications.
The pulse wave velocity (PWV) is a measure of arterial elasticity. An increase
in arterial stiffness is associated with an increased cardiovascular risk and
even an independent predictor of mortality in patients with T2DM. The PWV can
be measured by use of velocity encoded magnetic resonance imaging (MRI).
Insulin resistance and hyperglycemia are involved in different processes
leading to endothelial dysfunction.
In patients with T2DM chronic hyperglycemia is involved in the formation of
advanced glycation products (AGEs), which can also increase arterial stiffness.
Study objective
We aim to study the short-term effects of postprandial hyperglycemia in
patients with impaired fasting glucose and in patients with T2DM on aortic
stiffness as measured by PWV.
Secondly, we study the effects of postprandial hyperglycemia on the sympathetic
activity in those subjects.
Study design
Random assignment, placebo-controlled, cross-over design with 2 study days
separated by 7-day intervals.
Intervention
Oral glucose tolerance test
Study burden and risks
Three visits, including screening are applicable to all subjects. At screening
and during the MRI scan blood samples will be taken via venous puncture or iv
cannula. There are no inherent hazards from MRI when MR exclusion criteria have
been checked. During the MRI scan patients have to lie still inside the small
bore of the MRI machine. This may cause some discomfort. This will be as much
possible alleviated by the possibility of playing music CD*s brought by the
patients themselves. During changing of surface coils, patients can move
freely, and can visit the restroom if needed.
Albinusdreef 2
2333 ZA LEIDEN
NL
Albinusdreef 2
2333 ZA LEIDEN
NL
Listed location countries
Age
Inclusion criteria
For all: Age: 18-65 years, informed consent.
Patients with T2DM: untreated or treated with oral glucose lowering agents
HbA1c < 8.5%
Subjects with impaired fasting glucose: fasting glucose 5.6-6.9 mmol/l
Exclusion criteria
Healthy controls and impaired glucose tolerance: grade 2 or 3 hypertension at screening (ESC guidelines); use of glucose lowering mediaction/ statins or antihypertensives; any significant chronic disease; smoking; contra-indications MRI
Patients with type 2 diabetes: tension: >140/90 mmHg; use of insulin/ thiazolidinediones/ smoking/ contra-indications MRI
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 | NL30975.058.09 |