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NCT Number: NCT02130505

Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Familial Combined Hyperlipidemia Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperlipidemia, Familial Combined Hyperlipidemias Leukocyte Activation Disorder Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OGTT

Dietary Supplement

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

Primary outcomes

  1. Postprandial change in leukocyte activation

    Time frame: area under the curve during 2 hours

    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.

Secondary outcomes

  1. Correlation between chronic glycemia and leukocyte activation

    Time frame: area under the curve during 2 hours

    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.

  2. Correlation between acute glycemia and leukocyte activation

    Time frame: area under the curve during 2 hours

    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.

Sponsors and collaborators

Lead sponsor

Sint Franciscus Gasthuis

Other

Registry information

Acronym: INFORM

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 5, 2014
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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