Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

NCT02130505 | Completed

• 1 other identifier: NL17100.101.07
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Correlation between chronic glycemia and leukocyte activation

  area under the curve during 2 hours

• Correlation between acute glycemia and leukocyte activation

  area under the curve during 2 hours

Study Arms (4)

T2DM

ACTIVE COMPARATOR

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

Dietary Supplement: OGTT

FCH

ACTIVE COMPARATOR

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

FH

ACTIVE COMPARATOR

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

Dietary Supplement: OGTT

Healthy controls

ACTIVE COMPARATOR

Healthy controls

Dietary Supplement: OGTT

Interventions

OGTT DIETARY_SUPPLEMENT

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

FCH; FH; Healthy controls; T2DM

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• Aged 45-65 years
• BMI \< 35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Franciscus Gasthuis: lead

Related Publications (1)

• de Vries MA, Alipour A, Klop B, van de Geijn GJ, Janssen HW, Njo TL, van der Meulen N, Rietveld AP, Liem AH, Westerman EM, de Herder WW, Cabezas MC. Glucose-dependent leukocyte activation in patients with type 2 diabetes mellitus, familial combined hyperlipidemia and healthy controls. Metabolism. 2015 Feb;64(2):213-7. doi: 10.1016/j.metabol.2014.10.011. Epub 2014 Oct 16.

  PMID: 25456098 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Diabetes Mellitus, Type 2; Hyperlipidemia, Familial Combined

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Manuel Castro Cabezas, MD, PhD

  Sint Franciscus Gasthuis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: May 5, 2014
• Study Start: June 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 5, 2014

Record last verified: 2014-05