Evaluation of High-Density Lipoprotein in Obesity Study

NeuroTherapia, Inc.

Status: Terminated

Conditions: Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT00912236

09-302

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

77 participants in 3 patient groups

1

Description:

BMI 20-25 kg/m2

2

Description:

BMI \> 30 kg/m2 with low TG (\<150) and normal HDL (\>50 for females, \>40 for males)

3

Description:

BMI \> 30 kg/m2 with high TG (\>150) and low HDL (\<50 for females, \<40 for males)