Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01584856
Enrollment
60
Registered
2012-04-25
Start date
2006-05-31
Completion date
2013-01-31
Last updated
2012-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes / Type 2 Diabetes

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).

Interventions

None listed

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026