HyperlipidemiasNCT00525109
Elevated Serum HDL in Four Generations of a Nashville Family
An observational study of Hyperlipidemias, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the genetic basis of one family's hereditary hyper-HDL-emia using multiple modalities such as linkage analysis and gene array. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2006
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Family
Who may be able to join
- 26 living members of a family with HDL levels greater than 90mg/dl and several of whom will act as related age matched controls.
- The investigators will also identify individuals in a lipid core database with HDL's of greater than 90mg/dl who have normal or low LDL and triglyceride levels and determine if they have normal or low LDL and triglyceride levels and determine if they have family members (parents or siblings) who also have high HDL cholesterol.
Who cannot join
- Individuals who are not a member of the study family and individuals with high HDL's and elevated LDL and/or triglycerides.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to determine the genetic basis of one family's hereditary hyper-HDL-emia using multiple modalities such as linkage analysis and gene array.
Read the detailed description
HDL, or good cholesterol, has been shown to protect against heart attack and stroke. How HDL works as a protective agent is not well understood. There is a family that has 4 generations of living members with high HDL level. In the study, after consent is obtained, we will obtain 2 tablespoons of blood from all the family members in order to study their cholesterol levels and to obtain DNA in order to determine if there is a pattern of inheritance for this trait. We will also have them fill out a questionnaire about their medical history, diet and activity level as all of these can affect their HDL levels. In addition we will obtain additional blood (about 2 tablespoons) for plasma, white blood cells and also perform a biopsy to obtain skin cells from a matched pair of family members with and without the trait in order to determine which genes might be turned on and off because of this trait. We also wish to study other families who have members with high HDL cholesterol as well. These individuals will be identified from a core database.
- Conditions
- Hyperlipidemias
- Being tested
- No Intervention
- Keywords
- Cholesterol, Hyperlipidemia, Gene array
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Single family cohort Receives: Other: No Intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJun 2004
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: Unable to complete enrollment due lack of family interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Muldowney, Vanderbilt University
- Investigators
- Douglas E Vaughan, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525109
- Sponsor's protocol ID
- 010535
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2007
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Serum HDL in Four Generations of a Nashville Family
- ClinicalTrials.gov ID
- NCT00525109
- Acronym / sponsor ID
- 010535
- Conditions
- Hyperlipidemias
- Keywords
- Cholesterol, Hyperlipidemia, Gene array
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to complete enrollment due lack of family interest.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Sep 2007 (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.
The purpose of this study is to determine the genetic basis of one family's hereditary hyper-HDL-emia using multiple modalities such as linkage analysis and gene array.
Detailed description
HDL, or good cholesterol, has been shown to protect against heart attack and stroke. How HDL works as a protective agent is not well understood. There is a family that has 4 generations of living members with high HDL level. In the study, after consent is obtained, we will obtain 2 tablespoons of blood from all the family members in order to study their cholesterol levels and to obtain DNA in order to determine if there is a pattern of inheritance for this trait. We will also have them fill out a questionnaire about their medical history, diet and activity level as all of these can affect their HDL levels. In addition we will obtain additional blood (about 2 tablespoons) for plasma, white blood cells and also perform a biopsy to obtain skin cells from a matched pair of family members with and without the trait in order to determine which genes might be turned on and off because of this trait. We also wish to study other families who have members with high HDL cholesterol as well. These individuals will be identified from a core database.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No InterventionSingle family cohort |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Family
Key inclusion criteria (2 listed)
- 26 living members of a family with HDL levels greater than 90mg/dl and several of whom will act as related age matched controls.
- The investigators will also identify individuals in a lipid core database with HDL's of greater than 90mg/dl who have normal or low LDL and triglyceride levels and determine if they have normal or low LDL and triglyceride levels and determine if they have family members (parents or siblings) who also have high HDL cholesterol.
Key exclusion criteria (1 listed)
- Individuals who are not a member of the study family and individuals with high HDL's and elevated LDL and/or triglycerides.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention | Other | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Unable to complete enrollment due lack of family interest.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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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.
Douglas E Vaughan, MD principal investigator
Vanderbilt University Medical Center
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 Hyperlipidemias, run by Vanderbilt University Medical Center 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 2 inclusion and 1 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 20 Mar 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: Unable to complete enrollment due lack of family interest.). 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.
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 20 Mar 2017.