Metabolic Syndrome XNCT00074451
Genomewide Search for Loci Underlying Metabolic Syndrome
An observational study of Metabolic Syndrome X and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify the genes involved in the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Metabolic Syndrome X, Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2003to Aug 2008
- 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 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To identify the genes involved in the metabolic syndrome.
Read the detailed description
BACKGROUND:
Metabolic syndrome, characterized by clustering of multiple metabolic abnormalities including abdominal obesity, dyslipidemia, hyperinsulinemia, hyperglycemia, and hypertension, is one of the most important risk factors for cardiovascular disease and stroke. Genetics play a significant role in determining the individual susceptibility to metabolic syndrome and the inter-individual variation in its associated phenotypes, though these genetic factors remain largely unknown. The long-term goal is to identify the metabolic syndrome susceptibility genes and their functional variants.
DESIGN NARRATIVE:
The goal of the research is to study the underlying phenotypic structure of the metabolic syndrome and to systematically search for genetic loci predisposing to the metabolic syndrome using the genome scan approach. The specific aims are: (1) to screen about 10,000 sibling pairs aged 40 to 64 years in Anqing, Anhui China, on intermediate phenotypes of the metabolic syndrome including body mass index, waist and hip circumference, serum lipid profiles (triglyceride, HDL-, LDL-, and total cholesterol), fasting serum glucose and insulin level, and blood pressure; (2) to study the underlying phenotypic structure of the metabolic syndrome in the about 10,000 ascertained sibling pairs using factor analysis; (3) to select and genome scan 800 nuclear families from the pool of the ascertained sibling pairs using Weber screening set 10 markers. Each selected nuclear family contains a "proband" and >=3 other family members. The values of the three most significant factors for metabolic syndrome in the factor analysis (see specific aim 2) will be used to classify "proband" status for each subject. A "proband" is defined as having >=2 out of 3 factor values falling into the same side of the 10/90 percentile tails of the corresponding age- and sex-adjusted population distributions; (4) to test for linkage in the genome-scanned families on intermediate phenotypes and factors of metabolic syndrome using the Unified Haseman-Elston method. In addition to the univariate test, linkage analysis will be performed using a novel multivariate version of the Unified H-E method, which has recently been proposed and shown to be significantly more powerful than the univariate test for traits with common genetic determinants; (5) to perform expansion or replication linkage studies on loci identified in the genome scan in 300-400 additional families with >=1 proband with a denser set of markers.
- Conditions
- Metabolic Syndrome X, Cardiovascular Diseases, Heart Diseases, Obesity, Hypertension, Hyperinsulinism
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases, Heart Diseases, Obesity, Hypertension, Hyperinsulinism, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2003 (estimated)
- Study startSep 2003
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Xu Xin, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074451
- Sponsor's protocol ID
- 1241
- Other IDs
- R01HL073882
- Status last verified
- Aug 2008
- First submitted
- 12 Dec 2003
- Last updated
- 11 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomewide Search for Loci Underlying Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00074451
- Acronym / sponsor ID
- 1241
- Conditions
- Metabolic Syndrome X, Cardiovascular Diseases, Heart Diseases, Obesity, Hypertension, Hyperinsulinism
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Dec 2003 (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.
To identify the genes involved in the metabolic syndrome.
Detailed description
BACKGROUND:
Metabolic syndrome, characterized by clustering of multiple metabolic abnormalities including abdominal obesity, dyslipidemia, hyperinsulinemia, hyperglycemia, and hypertension, is one of the most important risk factors for cardiovascular disease and stroke. Genetics play a significant role in determining the individual susceptibility to metabolic syndrome and the inter-individual variation in its associated phenotypes, though these genetic factors remain largely unknown. The long-term goal is to identify the metabolic syndrome susceptibility genes and their functional variants.
DESIGN NARRATIVE:
The goal of the research is to study the underlying phenotypic structure of the metabolic syndrome and to systematically search for genetic loci predisposing to the metabolic syndrome using the genome scan approach. The specific aims are: (1) to screen about 10,000 sibling pairs aged 40 to 64 years in Anqing, Anhui China, on intermediate phenotypes of the metabolic syndrome including body mass index, waist and hip circumference, serum lipid profiles (triglyceride, HDL-, LDL-, and total cholesterol), fasting serum glucose and insulin level, and blood pressure; (2) to study the underlying phenotypic structure of the metabolic syndrome in the about 10,000 ascertained sibling pairs using factor analysis; (3) to select and genome scan 800 nuclear families from the pool of the ascertained sibling pairs using Weber screening set 10 markers. Each selected nuclear family contains a "proband" and >=3 other family members. The values of the three most significant factors for metabolic syndrome in the factor analysis (see specific aim 2) will be used to classify "proband" status for each subject. A "proband" is defined as having >=2 out of 3 factor values falling into the same side of the 10/90 percentile tails of the corresponding age- and sex-adjusted population distributions; (4) to test for linkage in the genome-scanned families on intermediate phenotypes and factors of metabolic syndrome using the Unified Haseman-Elston method. In addition to the univariate test, linkage analysis will be performed using a novel multivariate version of the Unified H-E method, which has recently been proposed and shown to be significantly more powerful than the univariate test for traits with common genetic determinants; (5) to perform expansion or replication linkage studies on loci identified in the genome scan in 300-400 additional families with >=1 proband with a denser set of markers.
Study design
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 11 Feb 2019.
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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.
Xu Xin principal investigator
Harvard School of Public Health (HSPH)
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 11 Feb 2019.