HyperlipidemiaNCT00451464
Studies of Apolipoprotein Genotyping on the Drug Treatment of Hyperlipidemic Patients
An observational study of Hyperlipidemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cardiovascular-related diseases have been the majorities of the leading ten causes of death in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the modifiable factors (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2002to Jan 2005
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hyperlipidemia
Who cannot join
- Liver and kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular-related diseases have been the majorities of the leading ten causes of death in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the modifiable factors (e.g. the effect of drug treatment). Genetic epidemiology has being widely used to analyze the underline risk of cardiovascular diseases and to point the direction of treatment or prevention.
Lipoprotein is composed of lipid and protein. The genetic variation or mutation of apolipoprotein, the protein of lipoprotein, has been linked to some lipid abnormality resulting severe atherosclerotic cardiovascular diseases. ApoA-I, apo A-II, apo A-IV, apo B100, apo B48, apo C-I, apo C-II, apo C-III, apo D, and apo E are currently thought to affect lipid abnormalities. In addition, it has been documented that genetic variations are presented among different races. Apolipoprotein genetic variations or genetic polymorphism study has been emerged as an important role in the field of genetic therapy. The purpose of this 3-year study is to continue the lipid study in our laboratory, identifying the apolipoprotein genotyping in our pooled hyperlipidemic patients and normal control subjects living in Taiwan. We will observe the incidence and link apo A-I, apo A-II, apo A-IV and apo C-III genetic variations to the related lipid abnormality and cardiovascular diseases. The changes of genotyping after lipid lowering drug treatment using statin or fibrate in hypercholesterolemic or hypertriglyceridemic patients is another goal of this project.
Read the detailed description
Cardiovascular-related diseases have been the majorities of the leading ten causes of death in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the modifiable factors (e.g. the effect of drug treatment). Genetic epidemiology has being widely used to analyze the underline risk of cardiovascular diseases and to point the direction of treatment or prevention.
Lipoprotein is composed of lipid and protein. The genetic variation or mutation of apolipoprotein, the protein of lipoprotein, has been linked to some lipid abnormality resulting severe atherosclerotic cardiovascular diseases. ApoA-I, apo A-II, apo A-IV, apo B100, apo B48, apo C-I, apo C-II, apo C-III, apo D, and apo E are currently thought to affect lipid abnormalities. In addition, it has been documented that genetic variations are presented among different races. Apolipoprotein genetic variations or genetic polymorphism study has been emerged as an important role in the field of genetic therapy. The purpose of this 3-year study is to continue the lipid study in our laboratory, identifying the apolipoprotein genotyping in our pooled hyperlipidemic patients and normal control subjects living in Taiwan. We will observe the incidence and link apo A-I, apo A-II, apo A-IV and apo C-III genetic variations to the related lipid abnormality and cardiovascular diseases. The changes of genotyping after lipid lowering drug treatment using statin or fibrate in hypercholesterolemic or hypertriglyceridemic patients is another goal of this project.
Our results showed ApoC-III (3175NT C→G) mutation was significantly related to hypertriglyceridemia, the same relation was also found in the Apo B exon 29 (13132 NT C→G; 4311 AA Asn →Ser) mutation. It is interesting to find some hot spot mutation among Caucasian population, such as Apo B exon 26 (10699 NT C→A; 3500 AA Arg →Gln), Apo A-IV (1527-2345 NT) and Apo E exon 2 mutations, were not found in tested samples. Most of presented allele frequencies in apolipoteins genes were different between our population and Caucasian population. The present results strongly suggest that it is necessary to establish our own genetic data which are linked to diseases.
- Conditions
- Hyperlipidemia
- Keywords
- Apolipoprotein, Gene polymorphism, Hyperlipidemia
- Medical subject headings
- Hyperlipidemias
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startJan 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chen Ming-Fong, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451464
- Sponsor's protocol ID
- 9100205283
- Other IDs
- NSC93-2314-B-002-016
- Status last verified
- Jul 2005
- First submitted
- 22 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Apolipoprotein Genotyping on the Drug Treatment of Hyperlipidemic Patients
- ClinicalTrials.gov ID
- NCT00451464
- Acronym / sponsor ID
- 9100205283
- Conditions
- Hyperlipidemia
- Keywords
- Apolipoprotein, Gene polymorphism, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jan 2005
- First posted
- 23 Mar 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.
Cardiovascular-related diseases have been the majorities of the leading ten causes of death in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the modifiable factors (e.g. the effect of drug treatment). Genetic epidemiology has being widely used to analyze the underline risk of cardiovascular diseases and to point the direction of treatment or prevention.
Lipoprotein is composed of lipid and protein. The genetic variation or mutation of apolipoprotein, the protein of lipoprotein, has been linked to some lipid abnormality resulting severe atherosclerotic cardiovascular diseases. ApoA-I, apo A-II, apo A-IV, apo B100, apo B48, apo C-I, apo C-II, apo C-III, apo D, and apo E are currently thought to affect lipid abnormalities. In addition, it has been documented that genetic variations are presented among different races. Apolipoprotein genetic variations or genetic polymorphism study has been emerged as an important role in the field of genetic therapy. The purpose of this 3-year study is to continue the lipid study in our laboratory, identifying the apolipoprotein genotyping in our pooled hyperlipidemic patients and normal control subjects living in Taiwan. We will observe the incidence and link apo A-I, apo A-II, apo A-IV and apo C-III genetic variations to the related lipid abnormality and cardiovascular diseases. The changes of genotyping after lipid lowering drug treatment using statin or fibrate in hypercholesterolemic or hypertriglyceridemic patients is another goal of this project.
Detailed description
Cardiovascular-related diseases have been the majorities of the leading ten causes of death in Taiwan. Atherosclerotic cardiovascular diseases are multifactorial. Some non-modifiable risk factors (e.g. genetic trait) may attenuate the benefit of risk modification of the modifiable factors (e.g. the effect of drug treatment). Genetic epidemiology has being widely used to analyze the underline risk of cardiovascular diseases and to point the direction of treatment or prevention.
Lipoprotein is composed of lipid and protein. The genetic variation or mutation of apolipoprotein, the protein of lipoprotein, has been linked to some lipid abnormality resulting severe atherosclerotic cardiovascular diseases. ApoA-I, apo A-II, apo A-IV, apo B100, apo B48, apo C-I, apo C-II, apo C-III, apo D, and apo E are currently thought to affect lipid abnormalities. In addition, it has been documented that genetic variations are presented among different races. Apolipoprotein genetic variations or genetic polymorphism study has been emerged as an important role in the field of genetic therapy. The purpose of this 3-year study is to continue the lipid study in our laboratory, identifying the apolipoprotein genotyping in our pooled hyperlipidemic patients and normal control subjects living in Taiwan. We will observe the incidence and link apo A-I, apo A-II, apo A-IV and apo C-III genetic variations to the related lipid abnormality and cardiovascular diseases. The changes of genotyping after lipid lowering drug treatment using statin or fibrate in hypercholesterolemic or hypertriglyceridemic patients is another goal of this project.
Our results showed ApoC-III (3175NT C→G) mutation was significantly related to hypertriglyceridemia, the same relation was also found in the Apo B exon 29 (13132 NT C→G; 4311 AA Asn →Ser) mutation. It is interesting to find some hot spot mutation among Caucasian population, such as Apo B exon 26 (10699 NT C→A; 3500 AA Arg →Gln), Apo A-IV (1527-2345 NT) and Apo E exon 2 mutations, were not found in tested samples. Most of presented allele frequencies in apolipoteins genes were different between our population and Caucasian population. The present results strongly suggest that it is necessary to establish our own genetic data which are linked to diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hyperlipidemia
Key exclusion criteria (1 listed)
- Liver and kidney disease
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 23 Mar 2007.
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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.
Chen Ming-Fong, MD, PhD principal investigator
National Taiwan University Hospital
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 Hyperlipidemia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 23 Mar 2007. 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 Taiwan. 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 23 Mar 2007.