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CompletedNCT02105909Updated Apr 7, 2014

GWAS in a Small Group of Metabolically Healthy Obese White Adults

An interventional study of GWAS in Obesity, sponsored by University of Nevada, Las Vegas. Completed. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-07.

Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

This is a GWAS pilot study that aims to identified possible candidate genes associate to obesity by exploring single nucleotide polymorphism (SNP) in a small group of obese , metabolically healthy white adults, matched with lean, white adults , metabolically healthy. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with obesity (as defined by BMI).

Read the detailed description

Between 60%-70% of the risk of obesity appears to be heritable. Unfortunately, the exact genes involved have been difficult to identify. New technologies now exist to help researchers discover obesity susceptibility genes. One of these technologies is the Affymetrix Genome-Wide Human SNP (single nucleotide polymorphism) Array 6.0 chips. SNPs are individual base pair differences in genes of different individuals, and they are the main source of human genetic diversity. The "chips" are thumbnail-size silicon surfaces that contain copies of hundreds of thousands of SNPs of the human genome (in this case around 900,000). SNP chips allow researchers to screen thousands of genes in a single experiment and compare genes of subjects with a particular disease or condition with unaffected control subjects. The investigators study utilizes SNP chips to compare the genetic profiles of obese subjects (N = 20, body mass index > 35 kg/m2) without common obesity-related co-morbidities such as diabetes mellitus or hypertension with well matched, lean controls (N = 20, body mass index 18-25 kg/m2). This is a pilot study intended to explore the following: 1) possible associations between obesity and previously unidentified obesity susceptibility genes; 2) associations between known obesity genes and obesity risk in subjects without obesity-related metabolic co-morbidities; and 3) how well our genetic data conform to other studies in similar populations as a way of assessing if the investigators have identified a representative cohort of obese subjects.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 81 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • Adults 40 year old or older
  • Caucasian males or females
  • BMI ≥ 35 kg/m² or history of BMI ≥ 35 kg/m², or BMi less than 25 kg/m2
  • No current or past use of glucose lowering drugs
  • No current or past medical history of diabetes mellitus
  • No current or past medical history of established coronary artery disease (angina, myocardial infraction, abnormal cardiac stress test)
  • No current or past medical history of or treatment for thyroid disorders
  • No current or past use of lipid lowering drugs or diagnosis of a lipid disorder
  • No current or past medical history of or treatment for hypertension
  • Subject's willingness to provide the study investigators with a copy of their medical records or give permission to the study investigators to access the following specific medical information:

    • Fasting plasma glucose (less than 100 mg/dL/5.6 mmol/L)
    • HDL-C cholesterol (more than 40 mg/dL /1.03 mmol/L)
    • Total cholesterol (less than 239 mg/dL/ 6.18mmol/L)
    • LDL cholesterol (less than 159 mg/dL/4.11 mmol/L)

Exclusion criteria

Exclusion Criteria:

    • Known monogenic forms of obesity
  • Polycystic ovary disease (in women)
  • Malabsorptive or maldigestive syndromes (Celiac disease, Crohn's Disease, inflammatory bowel disease, etc.)
  • Anorexia nervosa or bulimia
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    obese subjects

    DNA analysis

    Other: GWAS

  • Placebo comparator
    lean subjects

    DNA analysis

    Other: GWAS

Interventions

  • OtherGWAS
06

What researchers measure

Primary outcomes

  1. number of SNPs associated with high BMI

    Using GWAS to identify candidate genes associate with obesity (high BMI) in a carefully phenotyped white adults with obesity (as defined by BMI), metabolically healthy, matched with lean, white adults metabolically healthy.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02105909
Lead sponsor
University of Nevada, Las Vegas
Responsible party
Doina Kulick, MD (Associate Professor of Medicine, University of Nevada, Reno) — Principal investigator
First posted
Apr 7, 2014
Start date
May 2009
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Apr 7, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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