GWAS in a Small Group of Metabolically Healthy Obese White Adults
Genome Wide Association Studies (GWAS) to Identify Candidate Obesity Susceptibility Genes in a Carefully Phenotyped, Metabolically Healthy Population of Obese White Adults
1 other identifier
interventional
81
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started May 2009
Longer than P75 for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 26, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedApril 7, 2014
April 1, 2014
4.5 years
March 26, 2014
April 2, 2014
Conditions
Outcome Measures
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.
baseline
Study Arms (2)
obese subjects
EXPERIMENTALDNA analysis
lean subjects
PLACEBO COMPARATORDNA analysis
Interventions
Eligibility Criteria
You may qualify if:
- \- 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)
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
March 26, 2014
First Posted
April 7, 2014
Study Start
May 1, 2009
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
April 7, 2014
Record last verified: 2014-04