HypertriglyceridemiaNCT00018720
Regulation of Sterol Homeostasis
An observational study of Hypertriglyceridemia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine how people with high triglycerides metabolize and absorb bile acids, compounds made in the body from cholesterol. This project has two objectives: A) To define the mechanism of impaired bile acid absorption in hypertriglyceridemia (specifically we will determine if the active… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Dec 2000
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Hypertriglyceridemia and normal controls with normal lipids
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how people with high triglycerides metabolize and absorb bile acids, compounds made in the body from cholesterol.
This project has two objectives: A) To define the mechanism of impaired bile acid absorption in hypertriglyceridemia (specifically we will determine if the active or passive component of absorption is abnormal) and B) to determine the contribution of an alternative pathway of bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase is present in endothelial cells as well as liver, this pathway may play a role in removal of cholesterol from incipient atherosclerotic plaque.
- Conditions
- Hypertriglyceridemia
- Keywords
- triglyceride, bile acids, cholelithias
- Medical subject headings
- Hypertriglyceridemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startApr 1996
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Norman Javitt, M.D.Alan Hofmann, M.D.Loren Zech, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018720
- Sponsor's protocol ID
- GAST-026-95F
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Sterol Homeostasis
- ClinicalTrials.gov ID
- NCT00018720
- Acronym / sponsor ID
- GAST-026-95F
- Conditions
- Hypertriglyceridemia
- Keywords
- triglyceride, bile acids, cholelithias
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1996
- Study completion
- Dec 2000
- First posted
- 5 Jul 2001 (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 how people with high triglycerides metabolize and absorb bile acids, compounds made in the body from cholesterol.
This project has two objectives: A) To define the mechanism of impaired bile acid absorption in hypertriglyceridemia (specifically we will determine if the active or passive component of absorption is abnormal) and B) to determine the contribution of an alternative pathway of bile acid synthesis which begins with 27-hydroxylation of cholesterol. Because 27-hydroxylase is present in endothelial cells as well as liver, this pathway may play a role in removal of cholesterol from incipient atherosclerotic plaque.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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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.
Norman Javitt, M.D.
Alan Hofmann, M.D.
Loren Zech, M.D.
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 Hypertriglyceridemia, run by US Department of Veterans Affairs 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?
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: finished, as of the sponsor's last update on 21 Jan 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 21 Jan 2009.