Evaluation of High-Density Lipoprotein in Obesity Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- 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
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •BMI > 30 kg/m2
- •TG > 150 and
- •HDL < 50 (females) < 40 (males)
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)