GWAS to Identify Obesity Susceptibility Genes in Metabolically Healthy Obese Adults
This study aims to identify genes associated with obesity in metabolically healthy adults with a high BMI, by comparing them with lean, metabolically healthy adults through a Genome-Wide Association Study (GWAS).
GWAS
+ GWAS
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Diagnostic Study
Summary
Study start date: May 1, 2009
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.81 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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: - 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives