Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

Sint Franciscus Gasthuis51 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atherosclerosis Leukocyte Activation Disorder Type 2 Diabetes Mellitus Familial Combined Hyperlipidemia

Interventions

OGTTDIETARY_SUPPLEMENT

Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postprandial change in leukocyte activation

Leukocyte activation is determined by flow cytometry, using fluorescent labelled antibodies: FITC-conjugated anti-CD66b and PE-conjugated anti-CD11b, expressed in mean fluorescence intensity in arbitrary units. The difference in postprandial response, expressed as area under the curve, between patients with T2DM, FCH and healthy controls is determined using ANOVA.

Time frame: area under the curve during 2 hours

Secondary Outcomes

Correlation between chronic glycemia and leukocyte activation

To assess whether chronic hyperglycemia (HbA1c) correlates with postprandial leukocyte activation, correlation between HbA1c and postprandial leukocyte activation (area under the curve) will be determined for the total study group.

Time frame: area under the curve during 2 hours

Correlation between acute glycemia and leukocyte activation

To assess whether acute hyperglycemia correlates with postprandial leukocyte activation, correlation between fasting glucose levels and postprandial leukocyte activation (area under the curve) will be determined for the total study group.

Time frame: area under the curve during 2 hours

Data from ClinicalTrials.gov

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