Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00074451 |
| Other study ID # |
1241 |
| Secondary ID |
R01HL073882 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2003 |
| Est. completion date |
August 2008 |
Study information
| Verified date |
August 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To identify the genes involved in the metabolic syndrome.
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.
