To get more insight in the inflammatory processes induced by glucose in heallthy volunteers and patients with insulin dependent T2DM and hyperlipidemia.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lipid metabolism disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study, inflammatory aspects (leukocyte activation and complement
system) in different groups of subjects will be investigated during an OGTT.
Secondary outcome
Not applicable.
Background summary
Cardiovascular disease (CVD) is number one killer in the Netherlands. Insulin
resistance and dyslipideima are the main causes of CVD. Recently, we have shown
that there is an acute leukocyte activation after an oral glucose tolerance
test (OGTT) in patients with newly-diagnosed diabets mellitus type 2 (T2DM).
Leukocyte activation is an important and obligatory aspect in the process of
atherosclerosis. Complement system is another important inflammatory component
in atherosclerosis, which becomes activated in the postprandial phase.
In this study, we will investigate both inflammatory systems in healthy
volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both
familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during
an OGTT.
Study objective
To get more insight in the inflammatory processes induced by glucose in
heallthy volunteers and patients with insulin dependent T2DM and
hyperlipidemia.
Study design
Healthy subjects between 45 and 65 years will be recruited by advertisement in
Sint Franciscus Gasthuis Rotterdam (SFG). Patients with T2DM on insulin therapy
and hyperlipidemia will be recruited from the out patient clinics of the
internal and vascular medicine of SFG en type 2 (via dr. Castro Cabezas and dr.
Alipour). The patients will receive a letter, in which the study is explained.
One week after this letter the patients will be called by dr. alipour and asked
whether they want to participate. The healthy volunteers and the patients who
have agreed to participate will be invited for a meeting. In this meeting
written informed will be explained and obtained. Furthermore, medical and
family history, list of medication and some (anthropometric) measurements
(weight, length, waist circumference and bloodpressure) will be obtained.
20 healthy volunteers, 20 subjects with T2DM on insulin therapy and 40
hyperlipidemic subjects (20 with hypercholesterolemia and 20 with
hypercholesterolemia and hypertriglyceridemia) will be included. The subjects
will be scheduled to undergo the OGTT. Therefore, they will vist the laboratory
(while fasting for 10 hours). before (t=0 minuts) and after (t=60 en t=120
minuts) ingesting a standardised glucose, blood will be obtained in order to do
the measurements.
Study burden and risks
Except for the risks of peripheral intravenous blood sampling (hematoma) and
hyperglycemia in T2DM patients on insulin therapy (who are used to deal with
this condition), there will be no additional risks.
Kleiweg 500
3045 PM Rotterdam
Nederland
Kleiweg 500
3045 PM Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
·Provide written informed consent
·Aged 45-65 years
·BMI < 35 kg/m2
Exclusion criteria
·Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information
·Diabetes mellitus treated with oral antidiabetic medicine
.Type 1 diabetes mellitus
·peripheral artery and/or coronary disease
.Untreated hypertension
·Alcohol use > 2 units/day
·Aberrations in kidney, liver and thyroid function
·Use of any experimental medication within 6 months of the study
·The use of immunosuppressive drugs
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 | NL17100.101.07 |