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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
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 90 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01584856     History of Changes
Other Study ID Numbers: EK-1267
Study First Received: April 24, 2012
Last Updated: April 25, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on May 21, 2013