ObesityNCT02105909
GWAS in a Small Group of Metabolically Healthy Obese White Adults
A study testing GWAS in people with Obesity, run by University of Nevada, Las Vegas.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- GWAS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Nov 2013
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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)
Show all 14Show fewer
- 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)
Who cannot join
- - 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
About this study
Official title: Genome Wide Association Studies (GWAS) to Identify Candidate Obesity Susceptibility Genes in a Carefully Phenotyped, Metabolically Healthy Population of Obese White Adults
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.
- Conditions
- Obesity
- Being tested
- GWAS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWASOther
| Study group | Role | What they receive |
|---|---|---|
| obese subjects | Experimental | DNA analysis Receives: Other: GWAS |
| lean subjects | Placebo comparator | DNA analysis Receives: Other: GWAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMay 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doina Kulick, MD, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105909
- Sponsor's protocol ID
- NIH P20 RR-016464
- Status last verified
- Apr 2014
- First submitted
- 26 Mar 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome Wide Association Studies (GWAS) to Identify Candidate Obesity Susceptibility Genes in a Carefully Phenotyped, Metabolically Healthy Population of Obese White Adults
- ClinicalTrials.gov ID
- NCT02105909
- Acronym / sponsor ID
- NIH P20 RR-016464
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Apr 2014 (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.
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).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese subjects | Experimental | Other: GWASDNA analysis |
| lean subjects | Placebo comparator | Other: GWASDNA analysis |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- - 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
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GWAS | Other | lean subjects, obese subjects |
Primary outcome
number of SNPs associated with high BMI
Time frame: baseline
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.
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 7 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GWAS in people with Obesity, run by University of Nevada, Las Vegas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. 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 7 Apr 2014. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
number of SNPs associated with high BMI (time frame: baseline). It is what the study was designed to measure, not a finding.
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 7 Apr 2014.