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Clinical Trials/NCT00912236
NCT00912236
Terminated
Not Applicable

Evaluation of High-Density Lipoprotein in Obesity Study

The Cleveland Clinic1 site in 1 country77 target enrollmentJune 2009
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
The Cleveland Clinic
Enrollment
77
Locations
1
Primary Endpoint
To determine whether the functional activity of HDL is impaired in the setting of obesity
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

Obesity is associated with an impaired functioning HDL (good cholesterol) resulting in an acceleration in the development of atherosclerosis. This study will evaluate HDL functionality in patients with BMI (Body Mass Index) 20 - 25 and BMI >30

Detailed Description

This study will determine if the protective function of high-density lipoprotein (HDL) is impaired in obese patients and will help to enhance cardiovascular risk prediction. Carotid intima-media thickness (cIMT) will be captured as a means of assessing early vascular changes associated with low HDL levels in obesity. A novel measurement for clinical correlation has also been introduced called carotid extra-medial thickness (cEMT) which will be compared to cIMT in this obese population.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
March 2012
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 20-80
  • English speaking
  • BMI 20-25 kg/m2
  • Age 20-80
  • English speaking
  • BMI \> 30 kg/m2
  • TG \> 150 and
  • HDL \> 50 (females) \>40 (Males)
  • Age 20-80
  • English speaking

Exclusion Criteria

  • Self-reported history of:
  • Diabetes mellitus
  • Any previous lipid therapy within the last three months
  • Macrovascular events including TIA, stroke, myocardial infarction, heart failure, claudication, or known peripheral vascular disease
  • Current pregnancy

Outcomes

Primary Outcomes

To determine whether the functional activity of HDL is impaired in the setting of obesity

Time Frame: Within 2 weeks of enrollment

Secondary Outcomes

  • To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry(Within 2 weeks of enrollment)

Study Sites (1)

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