Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— INFORM  

Official title:

Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130505
• Other study ID #: NL17100.101.07
• Status: Completed
• Phase: N/A
• First received: April 21, 2014
• Last updated: May 1, 2014
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2014
• Source: Sint Franciscus Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus, Type 2
• Familial Combined Hyperlipidemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Leukocyte Activation Disorder
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• OGTT
Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sint Franciscus Gasthuis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	area under the curve during 2 hours	No
Secondary	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.	area under the curve during 2 hours	No
Secondary	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.	area under the curve during 2 hours	No