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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by University of Zurich.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584856
First Posted: April 25, 2012
Last Update Posted: April 26, 2012
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.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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).

Condition
Prediabetes / Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prediabetes / Type 2 Diabetes
Criteria

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.
  Contacts and Locations
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): NCT01584856


Locations
Switzerland
University Hospital Zurich, Endocrinology and Diabetology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Kaspar Berneis, Prof. MD University Hospital Zurich, Endocrinology and Diabetology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01584856     History of Changes
Other Study ID Numbers: EK-1267
First Submitted: April 24, 2012
First Posted: April 25, 2012
Last Update Posted: April 26, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia