Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes (INFORM)

Sint Franciscus Gasthuis

Status: Completed

Conditions: Leukocyte Activation Disorder; Type 2 Diabetes Mellitus; Familial Combined Hyperlipidemia; Atherosclerosis

Treatments: Dietary Supplement: OGTT

Study type: Interventional

Funder types: Other

Identifiers

NCT02130505

NL17100.101.07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 4 patient groups

T2DM

Active Comparator group

Description:

Patients with type 2 diabetes mellitus, defined as having met the diagnostic criteria as outlined by the World Health Organization

Treatment:

Dietary Supplement: OGTT

FCH

Active Comparator group

Description:

Patients with familial combined hyperlipidemia, defined as familial hyperlipidemia with a dominant inheritance pattern, elevated plasma apolipoprotein (apo) B concentrations (\>1.2 g/L) and elevated triglyceride (TG) levels (\>1.7 mmol/L) at the time of diagnosis

Treatment:

Dietary Supplement: OGTT

FH

Active Comparator group

Description:

Patients with familial hyperlipidemia, defined as having met the diagnostic criteria as outlined by the world Health Organization

Treatment:

Dietary Supplement: OGTT

Healthy controls

Active Comparator group

Description:

Healthy controls

Treatment:

Dietary Supplement: OGTT