Estudio de asociación del genoma completo para identificar genes de susceptibilidad a la obesidad en adultos obesos metabólicamente sanos
GWAS
+ GWAS
Peso Corporal+3
+ Trastornos de la Nutrición
+ Enfermedades Nutricionales y Metabólicas
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de mayo de 2009
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 81 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 40 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios