Evaluation of High-Density Lipoprotein in Obesity Study | NCT00912236

Studies
Evaluation of High-Density Lipoprotein in Obesity Study

NCT00912236

Sponsor

The Cleveland Clinic

Status

Terminated

Last Update Posted

Apr 13, 2017Actual

Enrollment

77Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator left institution

Expanded Access Info

Start Date

Jun 2009Actual

Primary Completion Date

Jun 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

May 20, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2017

Last Update Posted Date

Apr 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		BMI 20-25 kg/m2
2		BMI > 30 kg/m2 with low TG (<150) and normal HDL (>50 for females, >40 for males)
3		BMI > 30 kg/m2 with high TG (>150) and low HDL (<50 for females, <40 for males)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine whether the functional activity of HDL is impaired in the setting of obesity		Within 2 weeks of enrollment

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Study population will be selected from Cleveland Clinic outpatient departments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Nicholls, MBBS, PhD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

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Browse Branches

Not provided