Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
NCT ID: NCT02130505
Last Updated: 2014-05-05
Study Results
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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COMPLETED
NA
51 participants
INTERVENTIONAL
2007-06-30
2008-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
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
OGTT
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
OGTT
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
OGTT
Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose
Healthy controls
Healthy controls
OGTT
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
Eligibility Criteria
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Inclusion Criteria
* Aged 45-65 years
* BMI \< 35 kg/m2
Exclusion Criteria
* 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
45 Years
65 Years
ALL
Yes
Sponsors
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Sint Franciscus Gasthuis
OTHER
Responsible Party
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M.A. de Vries
MD
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.
Other Identifiers
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NL17100.101.07
Identifier Type: -
Identifier Source: org_study_id
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