Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes

NCT ID: NCT02130505

Last Updated: 2014-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerosis Leukocyte Activation Disorder Type 2 Diabetes Mellitus Familial Combined Hyperlipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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T2DM

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

Group Type ACTIVE_COMPARATOR

OGTT

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

OGTT

Intervention Type DIETARY_SUPPLEMENT

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

FH

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

Group Type ACTIVE_COMPARATOR

OGTT

Intervention Type DIETARY_SUPPLEMENT

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

Healthy controls

Healthy controls

Group Type ACTIVE_COMPARATOR

OGTT

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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OGTT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sint Franciscus Gasthuis

OTHER

Sponsor Role lead

Responsible Party

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M.A. de Vries

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Castro Cabezas, MD, PhD

Role: STUDY_CHAIR

Sint Franciscus Gasthuis

References

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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.

Reference Type DERIVED
PMID: 25456098 (View on PubMed)

Other Identifiers

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NL17100.101.07

Identifier Type: -

Identifier Source: org_study_id

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