Clinical trial NCT02130505: Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
Official title: Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Leukocyte Activation Disorder
Type 2 Diabetes Mellitus
Familial Combined Hyperlipidemia
Lead sponsor: Sint Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postprandial change in leukocyte activation
timeFrame: area under the curve during 2 hours
Secondary outcomes:
measure: Correlation between chronic glycemia and leukocyte activation
timeFrame: area under the curve during 2 hours
measure: Correlation between acute glycemia and leukocyte activation
timeFrame: area under the curve during 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Sint Franciscus Gasthuis
name: Manuel Castro Cabezas, MD, PhD
role: STUDY_CHAIR
References:
citation: de Vries MA, Alipour A, Klop B, van de Geijn GJ, Janssen HW, Njo TL, van der Meulen N, Rietveld AP, Liem AH, Westerman EM, de Herder WW, Cabezas MC. Glucose-dependent leukocyte activation in patients with type 2 diabetes mellitus, familial combined hyperlipidemia and healthy controls. Metabolism. 2015 Feb;64(2):213-7. doi: 10.1016/j.metabol.2014.10.011. Epub 2014 Oct 16.