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Small Dense Low-density Lipoprotein in Patients With Prediabetes and Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01584856
First received: April 24, 2012
Last updated: April 25, 2012
Last verified: April 2012
History of Changes

April 24, 2012
April 25, 2012
May 2006
January 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01584856 on ClinicalTrials.gov Archive Site
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Small Dense Low-density Lipoprotein in Patients With Prediabetes and Type 2 Diabetes
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It is known that small dense LDL particles are associated with an increased cardiovascular risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to their size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with small dense LDL particles compared to subjects with large LDL particles. This study aims at evaluating the predictive value of small dense LDL particles in patients with prediabetes and type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients with prediabetes or type 2 diabetes will be recruited for the study. Assessment will include medical history (risk factors), physical examination (blood pressure, BMI, waist-to-hip ratio), collection of serum, oral glucose tolerance test, measurement of intima media thickness and endothelial dysfunction by ultrasound. All measurements will be repeated after 2 years. Data will be analysed to assess whether the amount of small dense LDL particles can predict further structural and functional changes of the cardiovascular system or changes in the severity of the disease (insulin resistance).
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Prediabetes / Type 2 Diabetes
Prediabetes / Type 2 Diabetes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion criteria: - male gender

  • impaired fasting glucose OR type 2 diabetes (ADA criteria)
  • BMI > 25 kg/m2
  • given informed consent

Exclusion criteria: - HbA1c > 9.0%

  • insulin therapy
  • fasting glucose > 11mmol/l
  • total cholesterol > 6.5 mmol/l OR triglycerides > 2.5 mmol/l
  • malignant or severe renal, hepatic, pulmonary, neurological or psychiatric disease
  • alcohol or drug abuse
  • HIV infection.
Male
20 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01584856
EK-1267
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University of Zurich
University of Zurich
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Principal Investigator: Kaspar Berneis, Prof. MD University Hospital Zurich, Endocrinology and Diabetology
University of Zurich
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP