ObesityNCT00912236
Evaluation of High-Density Lipoprotein in Obesity Study
An observational study of Obesity, run by The Cleveland Clinic at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obesity
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be selected from Cleveland Clinic outpatient departments
Who may be able to join
- Group 1:
- Age 20-80
- English speaking
- BMI 20-25 kg/m2
- Group 2:
- Age 20-80
Show all 16Show fewer
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity, HDL, HDL functionality
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether the functional activity of HDL is impaired in the setting of obesity
Measured: Within 2 weeks of enrollment
Secondary outcomes (1)
To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry
Measured: Within 2 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionMar 2012
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Nicholls, MBBS, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912236
- Sponsor's protocol ID
- 09-302
- Status last verified
- Apr 2017
- First submitted
- 20 May 2009
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of High-Density Lipoprotein in Obesity Study
- ClinicalTrials.gov ID
- NCT00912236
- Acronym / sponsor ID
- 09-302
- Conditions
- Obesity
- Keywords
- Obesity, HDL, HDL functionality
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 77 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from Cleveland Clinic outpatient departments
Key inclusion criteria (16 listed)
- Group 1:
- Group 2:
- Group 3:
Key exclusion criteria (5 listed)
- Self-reported history of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether the functional activity of HDL is impaired in the setting of obesity
Time frame: Within 2 weeks of enrollment
1 secondary outcome
To determine whether HDL is more susceptible to oxidative modification ex-vivo in obese patients by mass spectrometry
Time frame: Within 2 weeks of enrollment
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Nicholls, MBBS, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether the functional activity of HDL is impaired in the setting of obesity (time frame: Within 2 weeks of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.