Evaluation of High-Density Lipoprotein in Obesity Study

Terminated

• Conditions: Obesity

• Registration Number: NCT00912236
• Lead Sponsor: The Cleveland Clinic

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 Timeline

• Study First Submitted: 2009-05-20
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2011-06
• Study Completion: 2012-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Group 1:

  • Age 20-80
  • English speaking
  • BMI 20-25 kg/m2

• Group 2:

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

• Group 3:

  • 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether the functional activity of HDL is impaired in the setting of obesity	Within 2 weeks of enrollment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States