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

NCT01584856 | Unknown

• 1 other identifier: EK-1267
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prediabetes / Type 2 Diabetes

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prediabetes / Type 2 Diabetes

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Endocrinology and Diabetology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kaspar Berneis, Prof. MD

  University Hospital Zurich, Endocrinology and Diabetology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: May 1, 2006
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 26, 2012

Record last verified: 2012-04

Locations

CH (1)