Evaluation of High-Density Lipoprotein in Obesity Study

Obesity Clinical Trial

Official title:

Evaluation of High-Density Lipoprotein in Obesity Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912236
• Other study ID #: 09-302
• Status: Terminated
• Phase: N/A
• First received: May 20, 2009
• Last updated: April 11, 2017
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: March 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether the functional activity of HDL is impaired in the setting of obesity		Within 2 weeks of enrollment
Secondary	To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry		Within 2 weeks of enrollment