Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes (INFORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130505
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
M.A. de Vries, Sint Franciscus Gasthuis

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Leukocyte Activation Disorder Type 2 Diabetes Mellitus Familial Combined Hyperlipidemia Dietary Supplement: OGTT Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
Study Start Date : June 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: T2DM
Patients with type 2 diabetes mellitus, defined as having met the diagnostic criteria as outlined by the World Health Organization
Dietary Supplement: OGTT
Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose

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

Active Comparator: FH
Patients with familial hyperlipidemia, defined as having met the diagnostic criteria as outlined by the world Health Organization
Dietary Supplement: OGTT
Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose

Active Comparator: Healthy controls
Healthy controls
Dietary Supplement: OGTT
Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130505


Sponsors and Collaborators
Sint Franciscus Gasthuis
Investigators
Layout table for investigator information
Study Chair: Manuel Castro Cabezas, MD, PhD Sint Franciscus Gasthuis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: M.A. de Vries, MD, Sint Franciscus Gasthuis
ClinicalTrials.gov Identifier: NCT02130505     History of Changes
Other Study ID Numbers: NL17100.101.07
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Atherosclerosis
Hyperlipidemia, Familial Combined
Diabetes Mellitus
Hyperlipidemias
Hyperlipoproteinemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn