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Cardiovascular DiseasesNCT00087919

Defining an Obesity QTL on Chromosome 3q

An observational study of Cardiovascular Diseases and Heart Diseases, run by Case Western Reserve University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the genetic basis of obesity by fine mapping an obesity quantitative trail linkage (QTL) linked to chromosome 3q. Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Heart Diseases, Obesity
How many people
1,931 participants
Where
No sites listed yet
Study dates
Jul 2004to May 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 18 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Maywood cohort DNA samples were obtained from a larger cohort of families enrolled in the studies of blood pressure at Loyola University in Maywood, IL. The survey enrolled a representative random sample of the population between the ages of 18 and 74, regardless of obesity phenotype. A subcohort of 775 unrelated participants was selected and oversampled at the upper and lower ends of the BMI distribution to increase the power. Nigerian cohort Study participants were recruited from Igbo-Ora and Ibadan in southwest Nigeria as part of a long-term study on the environmental and genetic factors underlying hypertension. The sample comprised 1098 unrelated adults with normal or elevated blood pressure and 155 unrelated participants from Ibadan with elevated blood pressure recruited as controls in the Africa-America Diabetes Mellitus (AADM) study.

The survey enrolled a representative random sample of the population the age of 18 and 74, regardless of obesity phenotype.

About this study

To investigate the genetic basis of obesity by fine mapping an obesity quantitative trail linkage (QTL) linked to chromosome 3q.

Read the detailed description

BACKGROUND:

In the last several decades obesity has emerged as a major public health threat. While prevention through lifestyle change is the only long-term solution, better understanding of the physiologic mechanisms would greatly assist development of drugs and targeted prevention. Obesity is a highly heritable condition and while genes must account for a substantial proportion of individual susceptibility they have eluded detection. Powerful new genetic and genomic tools now permit comprehensive evaluation of candidate genes, including all genes under linkage peaks. These tools include new genomic resources (the human genome sequence, databases of common SNPs, and the haplotype map), rapid and inexpensive discovery and genotyping and new analytic methods (haplotype-based association and admixture mapping).

DESIGN NARRATIVE:

In a large African American family set Dr. Zhu and colleagues have obtained strong linkage evidence for obesity on chromosome 3q (combined LOD score = 3.7). A prime candidate (adiponectin) lies near this peak. They propose to follow up that finding by combining the epidemiologic data with high-throughput genotyping and move from linkage to association analysis. The results for this QTL will be evaluated within the available environmental factors to assess potential gene-environment and gene-gene interactions. The available phenotypes include body composition, resting metabolic rate, physical activity, plasma insulin, glucose, and leptin. In a family-based design they will examine the linkage peak centered on position 188 cM on chromosome 3q (20 Cm 1-LOD support interval), with the following step-wise strategy: (a) Genotype 200 single nucleotide polymorphisms (SNPs) in this region on 300 families (1,000 individuals); (b) Conduct linkage, linkage disequilibrium and admixture mapping to potentially further narrow the region; and (c) Conduct resequencing and haplotype-based association studies for all candidate genes under the peak. Statistical analysis incorporating intermediate phenotypes and environmental covariates will be used to characterize potential gene x gene or gene x environment interactions. Replication will be tested in additional populations of African and European origin.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00087919
Study groupRoleWhat they receive
MaywoodThe were 743 subjects were sampled from Maywood, Il. There was no intervention.
NigeriaThere were 1188 Nigerian sampled from Igbo-Ora and Ibadan, Nigeria. There was no intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
1,931 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087919
Sponsor's protocol ID
1263
Other IDs
R01HL074166
Status last verified
Jul 2008
First submitted
15 Jul 2004
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by Case Western Reserve University.

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 23 Feb 2022. 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 23 Feb 2022.

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